Ravindran Research Lab - Biomarkers

Ravindran Research Lab

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Clinical Trials

Cariprazine (Study Closed)

Diagnosis: MDD

Study: A double-blind, placebo-controlled study of cariprazine as an adjunct to antidepressants in the treatment of patients with major depressive disorder who have had an inadequate response to antidepressants alone (12 week, randomized, double-blind, placebo-controlled)

This is a phase 3, multicenter study designed to assess the efficacy, safety, and tolerability of fixed dose (either 1.5 or 3 mg/day) cariprazine as an adjunctive therapy to antidepressant therapy in Major Depressive Disorder.

Inclusion:

18-65 years old
MDD (8 week to 18 month course of illness and HAMD-17 scores greater than 21)
Inadequate response to 1-3 antidepressants
Currently receiving antidepressant therapy

Exclusion:

Current psychiatric diagnosis other than MDD (excepting specific phobia)
Suicidality
Substance-related disorder within 3-months of study
Inadequate response to more than three antidepressant treatments
Intolerance to cariprazine or other drugs of the same class