To Evaluate the Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/17/2018
Start Date:April 29, 2013
End Date:July 27, 2015

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A Phase 3, Long-Term, Open-Label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

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 (MDD).


Inclusion Criteria:

- Patients who have provided consent prior to any study specific procedures

- Meet the 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, completion of Study RGH-MD-72 (either
double-blind or single-blind treatment periods) with continued ADT treatment.

Exclusion Criteria:

- Patients who do not meet the DSM-IV-TR criteria for MDD
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Leesburg, Florida 34748
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