A Study of Aripiprazole in Patients With Major Depressive Disorder

NCT00105196 | Completed Phase 3 Results

• 1 other identifier: CN138-165
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 34

Brief 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

Major Depressive Disorder

Keywords

Single or recurrent; non-psychotic episode of Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline (Week 8) and Week 14

Secondary Outcomes (4)

• Mean Change in Sheehan Disability Scale (SDS) Mean Score

  Baseline (Week 8) and Week 14

• Mean Change in SDS Item Score (Social Life)

  Baseline (Week 8) and Week 14

• Mean Change in SDS Item Score (Family Life)

  Baseline (Week 8) and Week 14

• Mean Change in SDS Item Score (Work/School)

  Baseline (Week 8) and Week 14

Other Outcomes (3)

• MADRS Response

  Baseline (Week 8) and Week 14

• Clinical Global Impression (CGI)-Improvement Response

  Baseline (Week 8) and Week 14

• MADRS Remission

  Baseline (Week 8) and Week 14

Study Arms (2)

A1

EXPERIMENTAL

Drug: Aripiprazole+ ADT

A2

PLACEBO COMPARATOR

Drug: Placebo+ ADT

Interventions

Aripiprazole+ ADT DRUG

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

Also known as: Abilify

A1

Placebo+ ADT DRUG

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

A2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (34)

University Of Alabama At Birmingham

Birmingham, Alabama, 35205, United States

Location

Sharp Mesa Vista Hospital

San Diego, California, 92123, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Cns Clinical Research Group

Coral Springs, Florida, 33065, United States

Location

Medical College Of Georgia

Augusta, Georgia, 30912, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Uptown Research Institute, Llc

Chicago, Illinois, 60640, United States

Location

Cunningham Clinical Research, Llc

Edwardsville, Illinois, 62025, United States

Location

Comprehensive Neuroscience, Inc.

Hoffman Estates, Illinois, 60194, United States

Location

Vine Street Clinical Research Center

Springfield, Illinois, 62711, United States

Location

Clinical Research Institute

Witchita, Kansas, 67211, United States

Location

Lsu Health Sciences Center

New Orleans, Louisiana, 70115, United States

Location

Pharmasite Research, Inc.

Baltimore, Maryland, 21208, United States

Location

Summit Research Network

Farmington Hills, Michigan, 48336, United States

Location

Summit Research Network

Flint, Michigan, 48507, United States

Location

University Of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Radiant Research Las Vegas

Las Vegas, Nevada, 89146, United States

Location

Behavioral Health Center

Charlotte, North Carolina, 28211, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45408, United States

Location

Phebe Tucker, Md

Oklahoma City, Oklahoma, 73104, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Southeast Health Consultants

Charleston, South Carolina, 29407, United States

Location

Usc School Of Medicine

Columbia, South Carolina, 29203, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

Radiant Research, Slc

Salt Lake City, Utah, 84107, United States

Location

University Of Utah School Of Medicine

Salt Lake City, Utah, 84132, United States

Location

University Of Virginia

Charlottesville, Virginia, 22903, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Northbrooke Research Center

Brown Deer, Wisconsin, 53223, United States

Location

Dean Foundation For Health Research & Education

Middleton, Wisconsin, 53562, United States

Location

Related Publications (6)

• Berman RM, Fava M, Thase ME, Trivedi MH, Swanink R, McQuade RD, Carson WH, Adson D, Taylor L, Hazel J, Marcus RN. Aripiprazole augmentation in major depressive disorder: a double-blind, placebo-controlled study in patients with inadequate response to antidepressants. CNS Spectr. 2009 Apr;14(4):197-206. doi: 10.1017/s1092852900020216.

  PMID: 19407731 BACKGROUND

• Stewart TD, Hatch A, Largay K, Sheehan JJ, Marler SV, Berman RM, Nelson JC. Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis. J Affect Disord. 2014 Jun;162:20-5. doi: 10.1016/j.jad.2014.03.017. Epub 2014 Mar 24.

  PMID: 24766999 DERIVED

• Fabian TJ, Cain ZJ, Ammerman D, Eudicone JM, Tang Y, Rollin LM, Forbes RA, Berman RM, Baker RA. Improvement in functional outcomes with adjunctive aripiprazole versus placebo in major depressive disorder: a pooled post hoc analysis of 3 short-term studies. Prim Care Companion CNS Disord. 2012;14(6):PCC.12m01394. doi: 10.4088/PCC.12m01394. Epub 2012 Dec 20.

  PMID: 23585999 DERIVED

• Dunner DL, Laubmeier KK, Manos G, Forbes RA, Baker RA, Berman RM. Beneficial effects of adjunctive aripiprazole in major depressive disorder are not dependent on antidepressant therapy history: a post hoc analysis of 3 randomized, double-blind, placebo-controlled trials. Prim Care Companion CNS Disord. 2012;14(6):PCC.12m01380. doi: 10.4088/PCC.12m01380. Epub 2012 Nov 22.

  PMID: 23585997 DERIVED

• Casey DE, Laubmeier KK, Marler SV, Forbes RA, Baker RA. Efficacy of adjunctive aripiprazole in major depressive disorder: a pooled response quartile analysis and the predictive value of week 2 early response. Prim Care Companion CNS Disord. 2012;14(3):PCC.11m01251. doi: 10.4088/PCC.11m01251. Epub 2012 May 31.

  PMID: 23106023 DERIVED

• Fava M, Dording CM, Baker RA, Mankoski R, Tran QV, Forbes RA, Eudicone JM, Owen R, Berman RM. Effects of adjunctive aripiprazole on sexual functioning in patients with major depressive disorder and an inadequate response to standard antidepressant monotherapy: a post hoc analysis of 3 randomized, double-blind, placebo-controlled studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m00994. doi: 10.4088/PCC.10m00994gre.

  PMID: 21731833 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2005
• First Posted: March 10, 2005
• Study Start: March 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 2, 2013
• Results First Posted: May 18, 2009

Record last verified: 2011-04

Locations

US (34)