Status:
COMPLETED
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response t...
Eligibility Criteria
Inclusion
- Male or female outpatients 18 to 65 years of age, inclusive.
- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
- Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
- Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).
Exclusion
- Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
- Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.
- History of meeting DSM-IV-TR criteria for:
- Depressive episode with psychotic or catatonic features.
- Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
- Schizophrenia, schizoaffective, or other psychotic disorder.
- Obsessive-compulsive disorder.
- Bulimia or anorexia nervosa.
- Dementia, amnesic, or other cognitive disorder.
- Mental retardation.
- Participants considered a suicide risk.
Key Trial Info
Start Date :
December 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2013
Estimated Enrollment :
819 Patients enrolled
Trial Details
Trial ID
NCT01469377
Start Date
December 15 2011
End Date
December 12 2013
Last Update
May 1 2018
Active Locations (72)
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1
Forest Investigative Site 077
Garden Grove, California, United States, 92845
2
Forest Investigative Site 019
National City, California, United States, 91950
3
Forest Investigative Site 039
Oceanside, California, United States, 92056
4
Forest Investigative Site 015
Orange, California, United States, 92868