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NCT00105196 · ClinicalTrials.gov registry record · Phase 3

A Study of Aripiprazole in Patients With Major Depressive Disorder

A Phase 3 study of Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
349
Enrollment target
20
Study locations

NCT00105196 is a Phase 3 study of Major Depressive Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 349 participants, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target. The trial reports 20 study locations across 14 states.

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The verdict

NCT00105196, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
349 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Major Depressive Disorder

Interventions

  • DRUG Aripiprazole+ ADT
  • DRUG Placebo+ ADT

Study Locations (20)

Illinois

  • Uptown Research Institute, Llc - Chicago
  • Cunningham Clinical Research, Llc - Edwardsville
  • Comprehensive Neuroscience, Inc. - Hoffman Estates
  • Vine Street Clinical Research Center - Springfield

Georgia

  • Medical College Of Georgia - Augusta
  • Carman Research - Smyrna

Michigan

  • Summit Research Network - Farmington Hills
  • Summit Research Network - Flint

Minnesota

  • University Of Minnesota - Minneapolis
  • Regions Hospital - Saint Paul

Alabama

  • University Of Alabama At Birmingham - Birmingham

California

  • Sharp Mesa Vista Hospital - San Diego

District of Columbia

  • George Washington University Medical Center - Washington D.C.

Florida

  • Cns Clinical Research Group - Coral Springs

Trial Details

FieldValue
Enrollment Target 349 participants
Start Date 2005-03
Est. Completion 2008-03
Phase Phase 3

Sponsor

Otsuka Pharmaceutical Development & Commercialization

221 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00105196

The ClinicalTrials.gov registry entry for NCT00105196 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 349 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Aripiprazole+ ADT is the first listed.

NCT00105196 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Illinois, Georgia, Michigan.

Frequently Asked Questions

What is clinical trial NCT00105196 about?

NCT00105196 is a clinical study titled "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 incomp...

What is the current status of trial NCT00105196?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 349 participants. The study started on 2005-03. Estimated completion is 2008-03.

What conditions does trial NCT00105196 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT00105196?

The interventions under investigation include: Aripiprazole+ ADT (DRUG), Placebo+ ADT (DRUG).

Who is sponsoring clinical trial NCT00105196?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00105196 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.