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

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Antidepressant + placebo; Drug: Antidepressant + cariprazine (1-2 mg/d); Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854100

RGH-MD-71

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo

Treatment:

Drug: Antidepressant + placebo

Cariprazine 0.1 - 0.3 mg

Experimental group

Description:

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose

Treatment:

Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)

Cariprazine 1.0 - 2.0 mg

Experimental group

Description:

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose

Treatment:

Drug: Antidepressant + cariprazine (1-2 mg/d)