NCT00683852

A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy (ADT) Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior ADT

Completed Phase 3 Results posted Last updated 21 June 2017

What this trial tests

Phase 3 trial testing Aripiprazole 5mg in Major Depressive Disorder in 225 participants. Completed in 1 September 2009.

Timeline

1 September 2008

Primary endpoint
1 September 2009

1 September 2009

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	225
Start date	1 September 2008
Primary completion	1 September 2009
Estimated completion	1 September 2009
Sites	1 location across United States

Drugs / interventions tested

• Aripiprazole 5mg
• Aripiprazole 2mg — full drug profile →
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate
  Time frame: 12 weeks
  The primary outcome was the difference in response rate (decrease in MADRS total score of at least 50%) using the SPCD (sequential parallel comparison design). The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items

Sponsor's own description

The purpose of this study is to determine whether a reduced dose of aripiprazole is effective in treating patients with major depressive disorder

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Second-generation antipsychotics for major depressive disorder and dysthymia.
   Komossa K, Depping AM, Gaudchau A, Kissling W, et al · · 2010 · cited 60× · PMID 21154393 · DOI 10.1002/14651858.cd008121.pub2
2. How should we design future mechanistic and/or efficacy clinical trials?
   Fava M. · · 2024 · cited 14× · PMID 37237086 · DOI 10.1038/s41386-023-01600-9
3. Efficacy of dose increase among nonresponders to low-dose aripiprazole augmentation in patients with inadequate response to antidepressant treatment: a randomized, double-blind, placebo-controlled, efficacy trial.
   Mischoulon D, Witte J, Levy M, Papakostas GI, et al · · 2012 · cited 14× · PMID 21939613 · DOI 10.4088/jcp.10m06541