Status:
COMPLETED
Safety and Efficacy of Cariprazine As Adjunctive 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
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
Eligibility Criteria
Inclusion
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
- Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.
Exclusion
- DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Key Trial Info
Start Date :
June 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2010
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00854100
Start Date
June 30 2009
End Date
December 6 2010
Last Update
March 5 2019
Active Locations (41)
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1
Forest Investigative Site 040
Phoenix, Arizona, United States, 85050
2
Forest Investigative Site 038
Scottsdale, Arizona, United States, 85254
3
Forest Investigative Site
Arcadia, California, United States, 91007
4
Forest Investigative Site
Encino, California, United States, 91316