Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Cariprazine; Drug: Antidepressant Therapy (ADT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01838876

RGH-MD-76

Details and patient eligibility

About

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).

Enrollment: 442 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Patients who do not meet the DSM-IV-TR criteria for MDD.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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442 participants in 1 patient group

Cariprazine + ADT

Experimental group

Description:

Cariprazine, flexible dose (titrated to a dose of 3.0 milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.

Treatment:

Drug: Antidepressant Therapy (ADT)

Drug: Cariprazine