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

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Antidepressant + placebo — DRUG
  Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
• Antidepressant + cariprazine (0.1-0.3 mg/day) — DRUG
  Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
• Antidepressant + cariprazine (1-2 mg/d) — DRUG
  Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Study Details

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.

Key Dates

Start date

Jun 30, 2009

Status verified

Feb 2019

Primary completion

Dec 6, 2010

Completion

Dec 6, 2010

Study Design

Enrollment

231 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
• Experimental: Cariprazine 0.1 - 0.3 mg
  Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose
• Experimental: Cariprazine 1.0 - 2.0 mg
  Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (Week 8) to Week 16 ]

Locations (41)

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