A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Antidepressant + Placebo
Drug: Antidepressant + Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00095758
CN138-163

Details and patient eligibility

About

This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Men and women, 18-65 years old
  • Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration.
  • Treatment history of an inadequate response to at least one and no more than three antidepressants.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,200 participants in 2 patient groups, including a placebo group

A1
Placebo Comparator group
Treatment:
Drug: Antidepressant + Placebo
A2
Active Comparator group
Treatment:
Drug: Antidepressant + Aripiprazole

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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