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

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine — DRUG
  Cariprazine capsules 1.5 to 4.5 mg/day
• Placebo — DRUG
  Dose-matched placebo capsule once per day
• Antidepressant Therapy (ADT) — DRUG
  ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Study Details

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

Key Dates

Start date

Nov 15, 2012

Status verified

Aug 2019

Primary completion

Jun 24, 2016

Completion

Jun 24, 2016

Study Design

Enrollment

1,022 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Placebo + ADT Lead-in
  Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
• Placebo Comparator: Placebo + ADT (Double-Blind)
  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).
• Experimental: Cariprazine + ADT (Double-Blind)
  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).
• Other: Placebo + ADT (Continued Treatment)
  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.

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period [ Time Frame: Baseline (Week 8) ]

Locations (83)

Find similar trials in Tucson, AZ

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