Past Trials

1. Population Pharmacokinetic Study in Adolescent Patients with Schizophrenia or Bipolar I Disorder Treated with Olanzapine.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Eli Lilly & Company, February 2000.

2. The Study of Olanzapine plus Fluoxetine in Combination for Treatment-resistant Depression Without Psychotic Features.Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Eli Lilly & Company, February 2000.

3. Olanzapine vs. Placebo in the Treatment of Adolescents with Schizophrenia. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Eli Lilly & Company, February 2000

4. Olanzapine vs. Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Eli Lilly & Company, February 2001.

5. A Phase III, Randomized, Multi-center, Double-blind, Parallel-group, Placebo-controlled Safety and Efficacy Study of ADDERALL XR® with an Open-label Extension, in the Treatment of Adolescents Aged 13-17 with Attention Deficit Hyperactivity Disorder (ADHD).Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Shire Pharmaceutical Development, Inc., February 2001.

6. A comparison of fasting triglyceride levels cohorts with schizophrenic and related disorder treated chronically with Olanzapine, Risperidone and typical anti-psychotics. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Eli Lily & Company; August 2001.

7. Olanzapine vs. Ziprasidone in the treatment of Schizophrenia.Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Eli Lily & Company; August 2001.
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8. Olanzapine vs. Risperidone in the treatment of Bipolar I disorder, mixed or manic. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Eli Lily & Company; August 2001.

9. The Efficacy and Safety of Risperidone in the treatment of Children and Adolescents with Schizophrenia. Principal Investigator: Jeanette E. Cueva, M.D.; Sponsor: Janssen/Medex; April 2001.

10. A Multi-center, Randomized, Double-blind Study and Tolerability Study of Flexible Doses of Aripiprazole and Olanzapine in the Treatment of Patients with Acute Schizophrenia. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Bristol Myers Squibb; October 2000.

11. A Multi-center, Randomized, Double-blind Study of Flexible Doses of Aripiprazole vs. Perphenazine in the Treatment of Patients with Treatment-Resistant Schizophrenia. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Bristol Myers Squibb; August 2000.

12. Olanzapine Plus Fluoxetine Combination Therapy in Treatment Resistant Depression: A Dosing Range Study: Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.: Sponsor: Eli Lilly and Co.; March 2000.

13. A Double-blind, 12-Month Continuation Protocol for Patients who Successfully Completed Protocol RO548. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Pfizer/Scirex; April 2000.

14. A Double-blind Multi-Center Study Comparing The Safety and Efficacy of Ziprasidone to Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder Needing Inpatient Care. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Pfizer/Scirex; April 2000.

15. A Multi-center, 10-Week, Randomized, Double-blind Study of Sertraline and Placebo in Children and Adolescents with Post-traumatic Stress Disorder. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Pfizer Pharmaceuticals Group; January 2003.

16. A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults with Attention-Defecit/Hyperactivity Disorder: with a Secondary Examination of Impact of Treatment on Family Functioning. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Eli Lilly & Company; 2004.

17. A Multi-center, Open-label Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2mg - 30mg) in the Treatment of Adolescent Patients with Schizophrenia, and Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed Episode. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Otsuka Maryland Research Institute, Inc., February 2005.

18. A Multi-center, Randomized, Double-blind, Placebo-controlled Study with Two Fixed Oral Doses of Aripiprazole (10mg or 30mg) in the Treatment of Adolescent Patients with Schizophrenia. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Otsuka Maryland Research Institute, Inc., 2005

19. A Multi-center, Randomized, Double-blind, Placebo-controlled Study of Two Fixed Oral Doses of Aripiprazole (10mg or 30mg) in the Treatment of Child and Adolescent Patients Aged 10-17 Years, with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features.Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Otsuka Maryland Research Institute, Inc., February 2005.

20. A Randomized, Multicenter, Double-Blind, Parallel Group Study to Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenia Patients. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Solvay Pharmaceuticals; January 2007.

21. A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients with Major Depressive Disorder.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Bristol-Myers Squibb Pharmaceutical Research Institute; March 2007.

22. A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of Pexacerfont (BMS-562086) in the Treatment of Outpatients with Generalized Anxiety Disorder.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Bristol-Myers Squibb Pharmaceutical Research Institute; July 2007.

23. An Open-Label Study of Tolerability, Safety, and Pharmacokinetics of Duloxetine in the Treatment of Children and Adolescents with Major Depressive Disorder. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Eli Lilly and Company; August 2007.

24. A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients with Major Depression Disorder.Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: PGx Health; January 2008.

25. A Phase III, Open-label Study of SPD503 in Children and Adolescents aged 6-17 with Attention Deficit Hyperactivity Disorder.Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Shire Pharmaceutical Development, Inc., February 2008.

26. A Phase III, Randomized, Multi-center, Double-blind, Parallel-group, Placebo-controlled Safety and Efficacy Study of SPD503 in Children and Adolescents aged 6-17 with Attention Deficit Hyperactivity Disorder.Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Shire Pharmaceutical Development, Inc., February 2008.

27. A 12 Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode.Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Eli Lilly, May 2008.

28. The Evaluation of LAMICTAL™ as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age.Principal Investigator: Jeanette Cueva, M.D., Co-Investigator: David Krakow, M.D.; Sponsor: GlaxoSmithKline, July 2008.

29. A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 With a Diagnosis of ADHD. Principal Investigator: Jeanette Cueva, M.D., Co-Investigator: David Krakow, M.D.; Sponsor: Shire Pharmaceutical Development, Inc., September 2008.

30. A Phase III, Open-Label, Extension, Multi-center, Safety and Efficacy Study of LDX in Adolescents Aged 13-17 with ADHD.Principal Investigator: Jeanette Cueva, M.D., Co-Investigator: David Krakow, M.D.; Sponsor: Shire Pharmaceutical Development, Inc., October 2008.

31. A Phase III, Randomized, Double-Blind, Multi-center, Parallel-Group, Placebo-Controlled, Forced-Dose Titration, Safety and Efficacy Study of LDX in Adolescents Aged 13-17 With ADHD. Principal Investigator: Jeanette Cueva, M.D., Co-Investigator: David Krakow, M.D.; Sponsor: Shire Pharmaceutical Development, Inc., October 2008.

32. A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZDXXXX in the Treatment of Generalized Anxiety Disorder (GAD). Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: AstraZeneca, February 2009.

33. A Multicenter, Long-Term, Open-Label Study to Assess the Safety and Tolerability of OPC-XXX as Adjunctive Therapy in the Treatment of Outpatients with Major Depressive Disorder.Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc., May 2009.

34. A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of OPC-XXX as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder.Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc., May 2009.

35. A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study of 3 Dosages of JNJ-XXX in the Treatment of Adult Subjects with Attention-Deficit/Hyperactivity Disorder.Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Johnson & Johnson Pharmaceutical Development & Commercialization, Inc., May 2009.

36. A Double-blind, placebo-controlled study of Cariprazine as adjunctive therapy in Major Depressive Disorder. Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Forest Laboratories, July 2009.

37. A Study to Assess the Long-Term Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Fluoxetine Only in the Relapse Prevention of Stabilized Patients with Treatment-Resistant Depression.Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Eli Lilly, August 2009.

38. A 12 week, randomized, double-blind, placebo-controlled, phase III safety trial of XXX tablets (100 milligrams daily) in women taking a selective serotonin or serotonin -norepinephrine reuptake inhibitor with decreased sexual desire and distress. Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Boehringer-Ingelheim Pharmaceuticals, March 2010.

39. A Phase 4, randomized, double-blind, multicenter, placebo-controlled, parallel group study evaluating the safety and efficacy of XXX on executive function (self-regulation) behaviors in adults with ADHD reporting clinically significant impairment of real-world executive function behavior. Principal Investigator: David Krakow, M.D., Co-Investigator: Jeanette Cueva, M.D.; Sponsor: Shire Pharmaceutical Development, Inc., April 2010.

40. A Phase III, Placebo-controlled, Long-Term Safety and Tolerability Study of TC-5214 as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: AstraZeneca, September 2010.

41. A Long-Term, Open-Label, Safety Study of LY2216684 12 to 18 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who are Partial Responders to SSRI Treatment.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Eli Lilly & Company, October 2010.

42. A Phase III, Placebo-controlled, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: AstraZeneca, January 2011.

43. A Phase IIIb, randomized, double blind, placebo-controlled, 13-week clinical trial to assess the efficacy and safety of Duloxetine 30/60 mg QD compared to placebo in adolescents with Juvenile Primary Fibromyalgia Syndrome. Continued efficacy and safety of Duloxetine 30/60 mg QD will be assessed in a 26-week, open-label treatment extension period.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Eli Lilly, May 2011.

44. A Multicenter, Randomized, Double-Blind, Active-Controlled, Comparative Fixed-Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients with Treatment Resistant Major Depression.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Bristol Meyers Squibb, June 2011.

45. A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Bristol Meyers Squibb, June 2011.

46. A Multicenter, Randomized, Double-Blind, Placebo controlled, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Children and Adolescent Outpatients with Major Depression a Placebo-Controlled, Comparative Fixed-Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients with Treatment Resistant Major Depression. Principal Investigator: Jeanette E. Cueva, M.D. Co- Investigator: David Sert Krakow, M.D.; Sponsor: Pfizer, June 2011.

47. A 6-month, Open-label, Multi-center, Flexible-dose Extension Study to the B2061032 Study to Evaluate the Safety, Tolerability and Efficacy of Desvenlafaxine Succinate Sustained-Release (DVS SR) Tablets in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder. Principal Investigator: Jeanette E. Cueva, M.D. Co- Investigator: David Sert Krakow, M.D.; Sponsor: Pfizer, June 2011.

48. A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Study to Investigate the Safety and Efficacy of 20 mg Tasimelteon versus Placebo in Adult Subjects with Major Depressive Disorder Followed by a 52-week Open-label Extension. Principal Investigator: David Sert Krakow, M.D. Co- Investigator: Jeanette E. Cueva, M.D.; Sponsor: Vanda Pharmaceuticals, September 2011.

49. The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant Principal Investigator: David Sert Krakow, M.D. Co- Investigator: Jeanette E. Cueva, M.D.; Sponsor: Shire Pharmaceuticals, October 2011.

50. A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant Principal Investigator: David Sert Krakow, M.D. Co- Investigator: Jeanette E. Cueva, M.D.; Sponsor: Shire Pharmaceuticals, October 2011.

51. A Double-blind, Placebo-controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy In Major Depressive Disorder Principal Investigator: David Sert Krakow, M.D. Co- Investigator: Jeanette E. Cueva, M.D.; Sponsor: Forest Research Institute, November 2011

52. A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: AstraZeneca, February 2012.

53. A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Shire Pharmaceuticals, January 2013.

54. A Phase 3, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults with Binge Eating Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Shire Pharmaceuticals, January 2013.

55. A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients with Generalized Anxiety Disorder.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Forest Research Institute, March 2013.

56. A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects with Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment. Principal Investigator: Jeanette Cueva. M.D., Co-Investigator: David Krakow, M.D.; Sponsor: Cerecor, November 2013.

57. A 6-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg Compared with Placebo in Adults with Attention Deficit/Hyperactivity Disorder (ADHD). Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Alcobra, February, 2014.

58. A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel- Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects with Bipolar I Depression.Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Sunovion, March, 2014.

59. A 104 Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Sunovion, March, 2014.

60. A Phase 3, 12-Month, Multicenter, Open-label, Safety Study of SEP-225289 in Adults with Attention Deficit Hyperactivity Disorder (ADHD).Principal Investigator: David Sert Krakow, M.D.,Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Sunovion, June, 2014.

61. A Phase 3 Efficacy and Safety Study of ALKS for the Adjunctive Treatment of Major Depressive Disorder (Study III).Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Alkermes, July, 2014.

62. Open Label Extention Study of ALKS for the Adjunctive Treatment of Major Depressive Disorder (Study III). Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Alkermes, July, 2014

63. A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study with Levomilnacipran ER in Patients with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Forest / Actavis, November, 2014.

64. A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Sponsor: Forest / Actavis, November, 2014.

65. A Multicenter Open Label Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients with Major Depressive Disorder. Principal Investigator: Jeanette E. Cueva, M.D.,Co-Investigator: David Sert Krakow, M.D.; Sponsor: Sponsor: Forest / Actavis, November, 2014.

66. An 8-WEEK, Randomized, Phase 2, Double-blind, Sequential Parallel-group Comparison Study of two dose levels of PF-06372865 Compared to Placebo as an Adjunctive Treatment in Outpatients with Inadequate Response to Standard of Care for Generalized Anxiety Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Pfizer, November, 2014.

67. A Randomized, Double-Blind, Placebo-Controlled Study of Intermittent Doses of CERC-301 in the Treatment of Subjects with Severe Depression Despite Antidepressant Treatment. Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Cerecor, May, 2015.

68. SEP360-221: A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults with Moderate to Severe Binge Eating Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Sunovion, September, 2015.

69. SHP465-306 A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years with Attention-deficit/Hyperactivity Disorder (ADHD). Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Shire, September, 2015.

70. SEP 360-322: An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults with Binge-eating Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Sunovion, March, 2016.

71. Vayarin_006: A Randomized, Sequential Parallel, Double-Blind, Placebo-Controlled Medical Food Study for the Safety and Efficacy of Vayarin® in Adults with Attention Deficit Hyperactivity Disorder (ADHD) - "SHARP." Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Enzymotec, May, 2016.

72. RAP-MD-01: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Allergan, July, 2016.

73. RAP-MD-04: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Allergan, July, 2016.

74. RAP-MD-06: An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients with Major Depressive Disorder.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Allergan, July, 2016.

75. ALK5461-217: A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder.Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D.; Sponsor: Alkermes, January, 2017.

76. SEP360-321: A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults with Moderate to Severe Binge Eating Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Sunovion, February, 2017.

77. NOPRODMDD0003: A Randomized, Multicenter, Crossover Study to Assess the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Subjects with Major Depressive Disorder.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Janssen Research & Development, January, 2018.

78. ALK 5461-218: A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder.Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Alkermes, November 2018.

79. SEP360-322: An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults with Binge-eating Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Sunovion.

80. RAP-MD-32: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Allergan, June 2018.

81. RAP-MD-33: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel in the Prevention of Relapse in Patients with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Allergan, July 2018.

82. AR.19.004: A Multicenter, Fixed-Dose, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulphate) in Adult Subjects (Ages 18-55) with Attention Deficit Hyperactivity Disorder (ADHD).Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Arbor Pharmaceuticals, LLC. October 2018.

83. 217-MDD-303: A Phase 3, Open-label, 1-year Study of the Safety, Tolerability, and Need for Re-treatment with Sage-217 in Adult Subjects with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Sage Therapeutics, Inc. March 2019.

84. 3111-302-001: A Double-blind, Placebo-controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients with Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Allergan, November 2018.

85.       A Multicenter, Randomized, Double-Blind,Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: Biohaven Pharmaceuticals, Inc., August 2019.  

86.      812P306: A Phase 3, Randomized,Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-DoseStudy of the Efficacy and Safety of SPN-812 in Adults withAttention-Deficit/Hyperactivity Disorder (ADHD). Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Arbor Pharmaceuticals, Inc. September 2019. 

87.      331-201-00079: A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy,Safety, and Tolerability of Brexpiprazole as Adjunctive Therapy in theMaintenance Treatment of Adults With Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Otsuka Pharmaceutical Development & Commercialization,Inc. December 2019.

88.      812P311: An Open-Label Extension Studyto Evaluate the Long-term Safety and Efficacy of SPN-812 in Adults withAttention-Deficit Hyperactivity Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Supernus Pharmaceuticals, Inc. January 2020.

89.      331-201-00148: A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled Trial of Brexpiprazole inTreatment of Children and Adolescents With Irritability Associated With AutismSpectrum Disorder. Principal Investigator: Jeanette E. Cueva, M.D.,Co-Investigator: David Sert Krakow, M.D.; Sponsor: Otsuka PharmaceuticalDevelopment & Commercialization, Inc. January 2020.

90.      331-201-00191: A Phase 3, Multicenter,Open-label Trial to Evaluate the Long-term Safety and Tolerability ofBrexpiprazole (OPC-34712) in the Treatment of Children and Adolescents withIrritability Associated with Autism Spectrum Disorder. Principal Investigator: Jeanette E.Cueva, M.D., Co-Investigator:David Sert Krakow, M.D.; Sponsor: OtsukaPharmaceutical Development & Commercialization, Inc. February 2020.


91.      331-201-00072: A Phase 3, Multicenter,Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as CombinationTherapy with Sertraline in the Treatment of Adults with Post-traumatic StressDisorder (IND No. 117, 549). Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Otsuka Pharmaceutical Development &Commercialization, Inc. March 2020.


92.      331-201-00242: A Multicenter,Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebofor the Treatment of Adults With Borderline Personality Disorder (IND No.141091). PrincipalInvestigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Otsuka Pharmaceutical Development & Commercialization,Inc. June 2020.  

93.      331-201-00242: A Multicenter,Open-Label Trial to Evaluate the Safety and Tolerability of Brexpiprazole inthe Treatment of Adult Subjects With Borderline Personality Disorder (IND No.141091). PrincipalInvestigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Otsuka Pharmaceutical Development & Commercialization,Inc. August 2020. 

94.     217-MDD-305; A Phase3,  Randomized, Double-Blind Study Comparing the Efficacy and Safety ofSage-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant versus inAdults with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Sage Therapeutics, September 2020. 

95.  082A201:A Multicenter, Double-blind,Randomized, Placebo-Controlled, Parallel-Group, Proof-of-concept Study toEvaluate the Efficacy and Safety of Oral ACT=539313 in the Treatment of Adultswith Moderate to Severe binge eating disorder: Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Indorsia, November 2020 

96.  BHV 4157-209: A Multicenter, 48-WeekOpen-Label Safety Study of  Adjunctive Troriluzole in Subjects withObsessive Compulsive Disorder: Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Biohaven Pharmaceuticals, November 2020 

97.   A Phase 3, Open-Label, 1-Year Study of theSafety, Tolerability, and Need for Retreatment with Sage-217 in Adult Subjectswith Major Depressive Disorder. Principal Investigator: David SertKrakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor:Sage Therapeutics, November 2020. 

98.  3110-305-002: A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluatethe Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant inthe Acute Treatment of Migraine, With or Without Aura in Children andAdolescents (Ages 6-17). Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Abbvie, December 2020 

99.  REL-1017-310: A Phase 3, Multicenter, Open-label Study toAssess the Long-term Safety or REL-1017 as a Treatment of Major DepressiveDisorder: PrincipalInvestigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D.; Sponsor: Relmada Therapeutics, December 2020. 

100.   An open-label pragmatic study to assess thereal-world effectiveness of Adhansia XRTM in treatment of adult and adolescentpatients with ADHD in the United States. Principle Investigator: DavidSert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: Adlon.,January 2021. 

101.  42847922MDD3001: A Phase 3, AMulticenter, Double-blind, Randomized Parallel-Group, Placebo-Controlled, Studyto Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapyto Antidepressants in Adult and Elderly Patients with Major Depressive Disorderwith Insomnia Symptoms Who Have Responded Inadequately to AntidepressantTherapy and an Open-labeled Long-term Safety Extension Treatment withSelorexant: Principal Investigator:David Sert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor:Janssen Research & Development, June 2021 

102. BN43546: A Phase 2, Randomized,Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study toEvaluate the Efficacy and Safety of Balovaptan in Adults with Post-TraumaticStress Disorder. Principal Investigator: DavidSert Krakow, M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: F.Hoffmann-La Roche LTD, February 2022  

103. REL-1017-301: A Phase 3, Multicenter,Randomized, Double-Blind, Placebo-Controlled Study to Assessthe Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major DepressiveDisorder(The RELIANCE-I Study). Principal Investigator: David Sert Krakow,M.D., Co-Investigator: Jeanette E. Cueva, M.D.; Sponsor: Relmada Therapeutics,March 2022103.                

104. A Phase 3, Multicenter, Randomized,Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy,Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the AcuteTreatment of Migraine With or Without Aura in Children and Adolescents (Ages6-17). PrincipalInvestigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: AbbVie,April 2022. 

105. A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety andTolerability of Oral Ubrogepant in the Acute Treatment of Migraine With orWithout Aura in Children and Adolescents (Ages 6-17) Principal Investigator: David Sert Krakow, M.D., Co-Investigator: JeanetteE. Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: AbbVie,April 2022. 

106.                 A randomized, Double-blind, Multicenter,Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, andTolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participantswith Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia andInadequate Response to Current Antidepressant Therapy. Principal Investigator: Jeanette E.Cueva, M.D., Co-Investigator: David Sert Krakow, M.D., Vivian S. Namale, M.D.; Sponsor: JanssenResearch & Development, March 2023.  

107.                 A Randomized, Double-Blind, Placebo-controlledMulticenter Study to Assess the Efficacy and Safety of Lumateperone asAdjunctive Therapy in the Treatment of Patients with Major Depressive Disorder.PrincipalInvestigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: Intra-CellularTherapies, Inc, March 2023. 

108.                 An Open-label, Long-term, Safety and EfficacyStudy of Aticaprant as Adjunctive Therapy in Adult and Elderly ParticipantsWith Major Depressive Disorder (MDD). Principal Investigator: Jeanette E. Cueva, M.D., Co-Investigator: David Sert Krakow, M.D, Vivian S.Namale, M.D.; Sponsor: Janssen Research & Development, April 2023. 

109.                 An Open-label, Multicenter Trial to Assess theSafety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatmentof Patients with Major Depressive Disorder. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: Intra-CellularTherapies, Inc., June 2023.  

110.                 A Phase 3, Randomized, Double-blind,Placebo-controlled Trial of Solriamfetol in Adults with ADHD. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: AxsomeTherapeutics, Inc., July 2023. 

111.                 A Randomized, Double-blind, Active-controlledStudy of AXS-05 for the Prevention of Relapse of Depressive Symptoms. Principal Investigator: David Sert Krakow, M.D., Co-Investigator: Jeanette E.Cueva, M.D., Vivian S. Namale, M.D.; Sponsor: AxsomeTherapeutics, Inc., January 2024.