Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01715805

RGH-MD-72

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Enrollment: 1,022 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have provided consent prior to any specific procedure
• Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
• Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,022 participants in 4 patient groups, including a placebo group

Placebo + ADT Lead-in

Other group

Description:

Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.

Treatment:

Drug: Placebo

Drug: Antidepressant Therapy (ADT)

Placebo + ADT (Double-Blind)

Placebo Comparator group

Description:

Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).

Treatment:

Drug: Placebo

Drug: Antidepressant Therapy (ADT)

Cariprazine + ADT (Double-Blind)

Experimental group

Description:

Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).

Treatment:

Drug: Antidepressant Therapy (ADT)

Drug: Cariprazine

Placebo + ADT (Continued Treatment)

Other group

Description:

Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.

Treatment:

Drug: Placebo

Drug: Antidepressant Therapy (ADT)