Skip to main content
OpenTrials
Completed

NCT Number: NCT00105196

A Study of Aripiprazole in Patients With Major Depressive Disorder

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Disease Attributes Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Of Alabama At Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of 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 adequate antidepressant trials.

Treatment and study plan

Aripiprazole+ ADT

Drug

Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Other names: Abilify

Placebo+ ADT

Drug

Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Primary outcomes

  1. Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)

    Time frame: Baseline (Week 8) and Week 14

    Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Secondary outcomes

  1. Mean Change in Sheehan Disability Scale (SDS) Mean Score

    Time frame: Baseline (Week 8) and Week 14

    Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

  2. Mean Change in SDS Item Score (Social Life)

    Time frame: Baseline (Week 8) and Week 14

    Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

  3. Mean Change in SDS Item Score (Family Life)

    Time frame: Baseline (Week 8) and Week 14

    Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

  4. Mean Change in SDS Item Score (Work/School)

    Time frame: Baseline (Week 8) and Week 14

    Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Other outcomes

  1. MADRS Response

    Time frame: Baseline (Week 8) and Week 14

    Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).

  2. Clinical Global Impression (CGI)-Improvement Response

    Time frame: Baseline (Week 8) and Week 14

    Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).

  3. MADRS Remission

    Time frame: Baseline (Week 8) and Week 14

    Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka America Pharmaceutical

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 10, 2005
Registry last updated
Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.