NCT00095758

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_3 major-depressive-disorder

Timeline
Completed

Started Sep 2004

Typical duration for phase_3 major-depressive-disorder

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

November 9, 2004

Last Update Submit

November 22, 2013

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in a depression rating scale at endpoint

Secondary Outcomes (1)

  • Change in a disability scale and Clinical Global Impression scale at endpoint

Study Arms (2)

A1

PLACEBO COMPARATOR
Drug: Antidepressant + Placebo

A2

ACTIVE COMPARATOR
Drug: Antidepressant + Aripiprazole

Interventions

Antidepressant + PlaceboDRUG

Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.

A1
Antidepressant + AripiprazoleDRUG

Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.

Also known as: Abilify
A2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Local Institution

Beverly Hills, California, United States

Location

Local Institution

Burbank, California, United States

Location

Local Institution

National City, California, United States

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Local Institution

Orange, California, United States

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Local Institution

Pasadena, California, United States

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Local Institution

Denver, Colorado, United States

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Local Institution

Farmington, Connecticut, United States

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Local Institution

Jacksonville, Florida, United States

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Local Institution

Orlando, Florida, United States

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Local Institution

Atlanta, Georgia, United States

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Local Institution

Rockville, Maryland, United States

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Local Institution

Albuquerque, New Mexico, United States

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Local Institution

Brooklyn, New York, United States

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Local Institution

New York, New York, United States

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Local Institution

Cincinnati, Ohio, United States

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Local Institution

Toledo, Ohio, United States

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Local Institution

Portland, Oregon, United States

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Local Institution

Pittsburgh, Pennsylvania, United States

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Local Institution

Memphis, Tennessee, United States

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Local Institution

Dallas, Texas, United States

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Local Institution

Houston, Texas, United States

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Local Institution

Arlington, Virginia, United States

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Local Institution

Herndon, Virginia, United States

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Local Institution

Richmond, Virginia, United States

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Local Institution

Bellevue, Washington, United States

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Local Institution

Seattle, Washington, United States

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Local Institution

Brown Deer, Wisconsin, United States

Location

Local Institution

Middleton, Wisconsin, United States

Location

Related Publications (12)

  • 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: 19192475BACKGROUND

  • 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):344-52. doi: 10.4088/PCC.08m00744gre.

    PMID: 20098527BACKGROUND

  • 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):440-7. doi: 10.4088/pcc.v10n0603.

    PMID: 19287552BACKGROUND

  • 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. doi: 10.1097/JCP.0b013e31816774f9.

    PMID: 18344725BACKGROUND

  • 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. doi: 10.1097/JCP.0b013e3181ac9b0b.

    PMID: 19593176BACKGROUND

  • 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: 24766999DERIVED

  • 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: 23585999DERIVED

  • 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: 23585997DERIVED

  • 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: 23106023DERIVED

  • 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: 21731833DERIVED

  • Weisler RH, Khan A, Trivedi MH, Yang H, Eudicone JM, Pikalov A, Tran QV, Berman RM, Carlson BX. Analysis of suicidality in pooled data from 2 double-blind, placebo-controlled aripiprazole adjunctive therapy trials in major depressive disorder. J Clin Psychiatry. 2011 Apr;72(4):548-55. doi: 10.4088/JCP.09m05495gre. Epub 2010 Aug 24.

    PMID: 20816039DERIVED

  • Boulton DW, Balch AH, Royzman K, Patel CG, Berman RM, Mallikaarjun S, Reeves RA. The pharmacokinetics of standard antidepressants with aripiprazole as adjunctive therapy: studies in healthy subjects and in patients with major depressive disorder. J Psychopharmacol. 2010 Apr;24(4):537-46. doi: 10.1177/0269881108096522. Epub 2008 Oct 2.

    PMID: 18832427DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Antidepressive AgentsAripiprazole

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

September 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

US(28)