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Major Depressive DisorderPhase 3NCT00105196

A Study of Aripiprazole in Patients With Major Depressive Disorder

A Phase 3 study testing Aripiprazole+ ADT in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Aripiprazole+ ADT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
349 participants
Where
34 sitesUnited States
Study dates
Mar 2005to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Medical College Of Georgia

    Augusta, Georgia, 30912

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • Northwest Clinical Research Center

    Bellevue, Washington, 98004

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35205

  • Northbrooke Research Center

    Brown Deer, Wisconsin, 53223

  • Southeast Health Consultants

    Charleston, South Carolina, 29407

  • Behavioral Health Center

    Charlotte, North Carolina, 28211

  • University Of Virginia

    Charlottesville, Virginia, 22903

  • Uptown Research Institute, Llc

    Chicago, Illinois, 60640

  • Usc School Of Medicine

    Columbia, South Carolina, 29203

  • Cns Clinical Research Group

    Coral Springs, Florida, 33065

  • Midwest Clinical Research Center

    Dayton, Ohio, 45408

  • Cunningham Clinical Research, Llc

    Edwardsville, Illinois, 62025

  • Summit Research Network

    Farmington Hills, Michigan, 48336

  • Summit Research Network

    Flint, Michigan, 48507

  • Comprehensive Neuroscience, Inc.

    Hoffman Estates, Illinois, 60194

  • Radiant Research Las Vegas

    Las Vegas, Nevada, 89146

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Dean Foundation For Health Research & Education

    Middleton, Wisconsin, 53562

  • University Of Minnesota

    Minneapolis, Minnesota, 55454

  • Lsu Health Sciences Center

    New Orleans, Louisiana, 70115

  • Phebe Tucker, Md

    Oklahoma City, Oklahoma, 73104

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Summit Research Network

    Portland, Oregon, 97210

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Radiant Research, Slc

    Salt Lake City, Utah, 84107

  • University Of Utah School Of Medicine

    Salt Lake City, Utah, 84132

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • Carman Research

    Smyrna, Georgia, 30080

  • Vine Street Clinical Research Center

    Springfield, Illinois, 62711

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Clinical Research Institute

    Witchita, Kansas, 67211

Other trials in United States

About this study

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.

Being tested
Aripiprazole+ ADT, Placebo+ ADT
Keywords
Single or recurrent, non-psychotic episode of Major Depressive Disorder
Medical subject headings
Depressive Disorder, Major, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole+ ADTDrug

    Also called Abilify

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

  • Placebo+ ADTDrug

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

Study groups in NCT00105196
Study groupRoleWhat they receive
A1ExperimentalNot described
Receives: Drug: Aripiprazole+ ADT
A2Placebo comparatorNot described
Receives: Drug: Placebo+ ADT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week 8) and Week 14

Secondary outcomes (4)

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

    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.

    Measured: Baseline (Week 8) and Week 14

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

    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.

    Measured: Baseline (Week 8) and Week 14

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

    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.

    Measured: Baseline (Week 8) and Week 14

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

    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.

    Measured: Baseline (Week 8) and Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00105196
Sponsor's protocol ID
CN138-165
Status last verified
Apr 2011
First submitted
9 Mar 2005
Last updated
2 Dec 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 19407731

  • 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.

    PubMed 24766999

  • 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.

    PubMed 23585999

  • 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.

    PubMed 23585997

  • 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.

    PubMed 23106023

  • 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.

    PubMed 21731833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole+ ADT in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) (time frame: Baseline (Week 8) and Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105196, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2013.

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