Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

• Status: Completed
• Trial end date: 2010-12-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Gedeon Richter Ltd.
• Treatments: Antidepressive Agents; Cariprazine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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