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Pasadena, California

  • Major Depressive Disorder

Purpose:

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.


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.


Study is Available At:


Original ID:

CN138-163


NCT ID:

NCT00095758


Secondary ID:


Study Acronym:


Brief Title:

A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder


Official Title:

A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1200


Enrollment Type:


Overall Contact Information

Official Name:Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Study Dates

Start Date:September 2004
Completion Date:December 2006
Completion Type:Actual
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:November 2013
Last Changed Date:November 22, 2013
First Received Date:November 9, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in a disability scale and Clinical Global Impression scale at endpoint
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in a depression rating scale at endpoint
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Antidepressant + Placebo
Description:Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
Arm Name:A1
Intervention Type:Drug
Name:Antidepressant + Aripiprazole
Description:Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
Arm Name:A2
Other Name:Abilify

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:A1
Study Arm Type:Active Comparator
Arm Name:A2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Otsuka America Pharmaceutical

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Fava M, Wisniewski SR, Thase ME, Baker RA, Tran QV, Pikalov A, Yang H, Marcus RN, Berman RM. Metabolic assessment of aripiprazole as adjunctive therapy in major depressive disorder: a pooled analysis of 2 studies. J Clin Psychopharmacol. 2009 Aug;29(4):362-7.
PMID:19593176
Reference Type:Reference
Citation:Marcus RN, McQuade RD, Carson WH, Hennicken D, Fava M, Simon JS, Trivedi MH, Thase ME, Berman RM. The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2008 Apr;28(2):156-65.
PMID:18344725
Reference Type:Reference
Citation:Thase ME, Trivedi MH, Nelson JC, Fava M, Swanink R, Tran QV, Pikalov A, Yang H, Carlson BX, Marcus RN, Berman RM. Examining the Efficacy of Adjunctive Aripiprazole in Major Depressive Disorder: A Pooled Analysis of 2 Studies. Prim Care Companion J Clin Psychiatry. 2008;10(6):440-447.
PMID:19287552
Reference Type:Reference
Citation:Nelson JC, Thase ME, Trivedi MH, Fava M, Han J, Van Tran Q, Pikalov A, Qi Y, Carlson BX, Marcus RN, Berman RM. Safety and Tolerability of Adjunctive Aripiprazole in Major Depressive Disorder: A Pooled Post Hoc Analysis (studies CN138-139 and CN138-163). Prim Care Companion J Clin Psychiatry. 2009;11(6):344-352.
PMID:20098527
Reference Type:Reference
Citation:Trivedi MH, Thase ME, Fava M, Nelson CJ, Yang H, Qi Y, Tran QV, Pikalov A, Carlson BX, Marcus RN, Berman RM. Adjunctive aripiprazole in major depressive disorder: analysis of efficacy and safety in patients with anxious and atypical features. J Clin Psychiatry. 2008 Dec;69(12):1928-36. Epub 2008 Dec 2.
PMID:19192475

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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