Status:
COMPLETED
Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Depressive Disorder
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious dis...
Detailed Description
The introduction of atypical antipsychotics has created a renewed interest in adjunctive therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics have been shown to e...
Eligibility Criteria
Inclusion
- Male and Female subjects between 18-65 years of age, with diagnosis of major depressive disorder with or without anxious distress
- Current depressive episode must be at least 8 weeks in duration
Exclusion
- Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome
- Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
- Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
837 Patients enrolled
Trial Details
Trial ID
NCT02196506
Start Date
July 1 2014
End Date
May 1 2016
Last Update
August 21 2018
Active Locations (47)
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1
Birmingham, Alabama, United States
2
Beverly Hills, California, United States
3
Denver, Colorado, United States
4
Hialeah, Florida, United States