Status:
COMPLETED
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (M...
Eligibility Criteria
Inclusion
- Patients who have provided consent prior to any study specific procedures
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD
- New patients must have ongoing inadequate response to protocol allowed ADTs as reported in Antidepressant Treatment Response Questionnaire (ATRQ)
- For rollover patients from RGH-MD-72 \[NCT01715805\], completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.
Exclusion
- Patients who do not meet the DSM-IV-TR criteria for MDD.
Key Trial Info
Start Date :
April 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2015
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT01838876
Start Date
April 29 2013
End Date
July 27 2015
Last Update
August 21 2019
Active Locations (90)
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1
Forest Investigative Site 032
Tucson, Arizona, United States, 85710
2
Forest Investigative Site 109
Tucson, Arizona, United States, 85724
3
Forest Investigative Site 105
Fayetteville, Arkansas, United States, 72703
4
Forest Investigative Site 018
Little Rock, Arkansas, United States, 72211