Major Depressive DisorderPhase 3NCT00095745
A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder
A Phase 3 study testing Antidepressant + Aripiprazole in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 58 sites in United States.
Trial summary
This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Antidepressant + Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 58 sitesUnited States
- Study dates
- Sep 2004to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18 years or older
- Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
- Treatment history of an inadequate response to at least one and no more than four antidepressants
Who cannot join
None listed.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Local Institution
Albuquerque, New Mexico
Local Institution
Arlington, Virginia
Local Institution
Atlanta, Georgia
Local Institution
Austin, Texas
Local Institution
Bellevue, Washington
Local Institution
Beverly Hills, California
Local Institution
Brooklyn, New York
Local Institution
Brown Deer, Wisconsin
Local Institution
Burbank, California
Local Institution
Chapel Hill, North Carolina
Local Institution
Charleston, South Carolina
Local Institution
Charlottesville, Virginia
Local Institution
Chicago, Illinois
Local Institution
Cincinnati, Ohio
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Dallas, Texas
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Denver, Colorado
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East Providence, Rhode Island
Local Institution
Edwardsville, Illinois
Local Institution
Encino, California
Local Institution
Farmington, Connecticut
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Farmington Hills, Michigan
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Gainesville, Florida
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Garden Grove, California
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Herndon, Virginia
Local Institution
Houston, Texas
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Jacksonville, Florida
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Lexington, Kentucky
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Memphis, Tennessee
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Mesa, Arizona
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Middleton, Wisconsin
Local Institution
Morgantown, West Virginia
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National City, California
Local Institution
New York, New York
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Oakbrook Terrace, Illinois
Local Institution
Okemos, Michigan
Local Institution
Orange, California
Local Institution
Orlando, Florida
Local Institution
Overland Park, Kansas
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Pasadena, California
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Peoria, Arizona
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Philadelphia, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania
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Portland, Oregon
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Raleigh, North Carolina
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Richmond, Virginia
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Riverside, California
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Rockville, Maryland
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Salt Lake City, Utah
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San Diego, California
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Seattle, Washington
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Smyrna, Georgia
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Springfield, Massachusetts
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Staten Island, New York
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Terre Haute, Indiana
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Toledo, Ohio
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Washington D.C., District of Columbia
Local Institution
Wichita, Kansas
Local Institution
Woodstock, Vermont
About this study
Official title: A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder
This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.
- Conditions
- Major Depressive Disorder
- Being tested
- Antidepressant + Aripiprazole
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antidepressant + AripiprazoleDrug
Also called Abilify
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Antidepressant + Aripiprazole | No intervention | Not described Receives: Drug: Antidepressant + Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startSep 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095745
- Sponsor's protocol ID
- CN138-164
- Status last verified
- Apr 2011
- First submitted
- 9 Nov 2004
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Clayton AH, Baker RA, Sheehan JJ, Cain ZJ, Forbes RA, Marler SV, Marcus R, Berman RM, Thase ME. Comparison of adjunctive use of aripiprazole with bupropion or selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors: analysis of patients beginning adjunctive treatment in a 52-week, open-label study. BMC Res Notes. 2014 Jul 18;7:459. doi: 10.1186/1756-0500-7-459.
PubMed 25037144
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00095745
- Acronym / sponsor ID
- CN138-164
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Sep 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antidepressant + Aripiprazole | No intervention | Drug: Antidepressant + Aripiprazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women, 18 years or older
- Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
- Treatment history of an inadequate response to at least one and no more than four antidepressants
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antidepressant + AripiprazoleAlso: AbilifyAntidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks. | Drug | Antidepressant + Aripiprazole |
Primary outcome
Safety assessments
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 25037144Clayton AH, Baker RA, Sheehan JJ, Cain ZJ, Forbes RA, Marler SV, Marcus R, Berman RM, Thase ME. Comparison of adjunctive use of aripiprazole with bupropion or selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors: analysis of patients beginning adjunctive treatment in a 52-week, open-label study. BMC Res Notes. 2014 Jul 18;7:459. doi: 10.1186/1756-0500-7-459.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antidepressant + Aripiprazole in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 58 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 3 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety assessments (time frame: throughout the study). 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 NCT00095745, which also lists 1 linked publication.
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 8 Nov 2013.