NCT00105196 is a Phase 3 clinical trial of Aripiprazole+ ADT in Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT00105196?

NCT00105196 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT00105196?

Interventions in NCT00105196: Aripiprazole+ ADT, Placebo+ ADT.

What condition does NCT00105196 study?

NCT00105196 studies Major Depressive Disorder.

Is NCT00105196 still recruiting?

NCT00105196 is currently completed. Last updated 7 November 2013.

Are results published for NCT00105196?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-11-07 · How we verify

NCT00105196

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Aripiprazole in Patients With Major Depressive Disorder

Completed Phase 3 Results posted Last updated 7 November 2013

What this trial tests

Phase 3 trial testing Aripiprazole+ ADT in Major Depressive Disorder in 349 participants. Completed in 1 March 2008.

Timeline

1 March 2005

Primary endpoint
1 March 2008

1 March 2008

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	349
Start date	1 March 2005
Primary completion	1 March 2008
Estimated completion	1 March 2008
Sites	34 locations across United States

Drugs / interventions tested

Aripiprazole+ ADT — full drug profile →
Placebo+ ADT

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline (Week 8) and Week 14
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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Aripiprazole augmentation in major depressive disorder: a double-blind, placebo-controlled study in patients with inadequate response to antidepressants.
Berman RM, Fava M, Thase ME, Trivedi MH, et al · · 2009 · cited 179× · PMID 19407731 · DOI 10.1017/s1092852900020216
Efficacy and safety of adjunctive aripiprazole in major depressive disorder in older patients: a pooled subpopulation analysis.
Steffens DC, Nelson JC, Eudicone JM, Andersson C, et al · · 2011 · cited 33× · PMID 20827794 · DOI 10.1002/gps.2564
Functioning outcomes with adjunctive treatments for major depressive disorder: a systematic review of randomized placebo-controlled studies.
Weiller E, Weiss C, Watling CP, Edge C, et al · · 2018 · cited 12× · PMID 29343962 · DOI 10.2147/ndt.s146840
Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis.
Stewart TD, Hatch A, Largay K, Sheehan JJ, et al · · 2014 · cited 12× · PMID 24766999 · DOI 10.1016/j.jad.2014.03.017
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.
Fava M, Dording CM, Baker RA, Mankoski R, et al · · 2011 · cited 11× · PMID 21731833 · DOI 10.4088/pcc.10m00994gre
Efficacy of adjunctive aripiprazole in major depressive disorder: a pooled response quartile analysis and the predictive value of week 2 early response.
Casey DE, Laubmeier KK, Marler SV, Forbes RA, et al · · 2012 · cited 4× · PMID 23106023 · DOI 10.4088/pcc.11m01251
Improvement in functional outcomes with adjunctive aripiprazole versus placebo in major depressive disorder: a pooled post hoc analysis of 3 short-term studies.
Fabian TJ, Cain ZJ, Ammerman D, Eudicone JM, et al · · 2012 · cited 3× · PMID 23585999 · DOI 10.4088/pcc.12m01394
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.
Dunner DL, Laubmeier KK, Manos G, Forbes RA, et al · · 2012 · cited 2× · PMID 23585997 · DOI 10.4088/pcc.12m01380

Verify or expand the search:

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials

Trials by the same sponsor.

NCT07525960 — A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for · Phase 1 · not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07455084 — A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults · Phase 1 · not yet recruiting
NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00105196 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 7 November 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00105196.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing