SchizophreniaPhase 4NCT00325689
Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
A Phase 4 study testing Quetiapine or Risperidone + Aripiprazole in people with Schizophrenia and Schizoaffective Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 48 sites in United States.
Trial summary
A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Quetiapine or Risperidone + Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 48 sitesUnited States
- Study dates
- Jul 2006to Oct 2007
- Phase
- Phase 4
- 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
- Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
- Stable symptoms and dose of Quetiapine or Risperidone
Who cannot join
- First diagnosis in the past year
- Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Sheppard Pratt Health System
Baltimore, Maryland, 21285
North Suffolk Mental Health Association
Boston, Massachusetts, 02114
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Comprehensive Neuroscience, Inc.
Cerritos, California, 90703
Uptown Research Institute, Llc
Chicago, Illinois, 60640
Cri Worldwide, Llc
Clementon, New Jersey, 08021
Saroj B. Brar, M.D., Inc.
Cleveland, Ohio, 44113
Department Of Veterans Affairs Medical Center
Coatesville, Pennsylvania, 19320
Atp Clinical Research, Inc.
Costa Mesa, California, 92626
Midwest Clinical Research Center
Dayton, Ohio, 45408
University Of Colorado At Denver And Health Sciences Center
Denver, Colorado, 80220
Duke University Health System
Durham, North Carolina, 27710
Advanced Bio-Behavioral Sciences
Elmsford, New York, 10523
Precise Research Centers
Flowood, Mississippi, 39232
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
San Fernando Mental Health Center
Granada Hills, California, 91344
Institute Of Living
Hartford, Connecticut, 06106
Alexian Center For Psychiatric Research
Hoffman Estates, Illinois, 60194
Medlabs Research Of Houston, Inc.
Houston, Texas, 77057
Indiana University School Of Medicine
Indianapolis, Indiana, 46202
K & S Professional Research Services, Llc
Little Rock, Arkansas, 72201
Suburban Research Associates
Media, Pennsylvania, 19063
University Of Minnesota
Minneapolis, Minnesota, 55454
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
New York State Psychiatric Institute
New York, New York, 10032
Manhattan Psychiatric Center
New York, New York, 10035
Behavioral Clinical Research, Inc
North Miami, Florida, 33161
Uci Medical Center
Orange, California, 92868
California Clinical Trials Medical Group
Paramount, California, 90723
Va Medical Center (116a)
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, 19131
Cri Worldwide, Llc
Philadelphia, Pennsylvania, 19149
Strong Ties Community Support Program
Rochester, New York, 14623
University Of Texas Health Science Center At San Antonio
San Antonio, Texas, 78229
California Clinical Trials
San Diego, California, 92123
Sharp Mesa Vista Hospital
San Diego, California, 92123
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, 92126
Schuster Medical Research Institute
Sherman Oaks, California, 91403
Lsu Health Sciences Center
Shreveport, Louisiana, 71103
J. Gary Booker, Md
Shreveport, Louisiana, 71104
Department Of Psychiatry And Behavioral Sciences
Stanford, California, 94305
Behavioral Medical Research Of Staten Island
Staten Island, New York, 10305
Richmond Behavioral Associates
Staten Island, New York, 10312
Va Puget Sound Health Care System
Tacoma, Washington, 98493
Community Counseling Of Bristol County, Inc. (Ccbc)
Taunton, Massachusetts, 02780
Pacific Clinical Research Medical Group
Upland, California, 91786
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.
A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Quetiapine or Risperidone + Aripiprazole, Quetiapine or Risperidone + placebo
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine or Risperidone + AripiprazoleDrug
Also called Abilify
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
Quetiapine or Risperidone + placeboDrug
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine or Risperidone + Aripiprazole | Active comparator | Not described Receives: Drug: Quetiapine or Risperidone + Aripiprazole |
| Quetiapine or Risperidone + placebo | Placebo comparator | Not described Receives: Drug: Quetiapine or Risperidone + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
Measured: (Week 16) or at time of discontinuation
Secondary outcomes (1)
Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)
Measured: at endpoint (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2007
- Study completionOct 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 SchizophreniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 323 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
- NCT00325689
- Sponsor's protocol ID
- CN138-397 ST
- Status last verified
- Apr 2011
- First submitted
- 11 May 2006
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
Kane JM, Correll CU, Goff DC, Kirkpatrick B, Marder SR, Vester-Blokland E, Sun W, Carson WH, Pikalov A, Assuncao-Talbott S. A multicenter, randomized, double-blind, placebo-controlled, 16-week study of adjunctive aripiprazole for schizophrenia or schizoaffective disorder inadequately treated with quetiapine or risperidone monotherapy. J Clin Psychiatry. 2009 Oct;70(10):1348-57. doi: 10.4088/JCP.09m05154yel.
PubMed 19906340
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, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.
- ClinicalTrials.gov ID
- NCT00325689
- Acronym / sponsor ID
- CN138-397 ST
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 May 2006 (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.
A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine or Risperidone + Aripiprazole | Active comparator | Drug: Quetiapine or Risperidone + Aripiprazole |
| Quetiapine or Risperidone + placebo | Placebo comparator | Drug: Quetiapine or Risperidone + placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
- Stable symptoms and dose of Quetiapine or Risperidone
Key exclusion criteria (2 listed)
- First diagnosis in the past year
- Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
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 |
|---|---|---|
| Quetiapine or Risperidone + AripiprazoleAlso: AbilifyTablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks. | Drug | Quetiapine or Risperidone + Aripiprazole |
| Quetiapine or Risperidone + placeboTablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks. | Drug | Quetiapine or Risperidone + placebo |
Primary outcome
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
Time frame: (Week 16) or at time of discontinuation
1 secondary outcome
Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)
Time frame: at endpoint (Week 16)
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.
- Background: PubMed 19906340Kane JM, Correll CU, Goff DC, Kirkpatrick B, Marder SR, Vester-Blokland E, Sun W, Carson WH, Pikalov A, Assuncao-Talbott S. A multicenter, randomized, double-blind, placebo-controlled, 16-week study of adjunctive aripiprazole for schizophrenia or schizoaffective disorder inadequately treated with quetiapine or risperidone monotherapy. J Clin Psychiatry. 2009 Oct;70(10):1348-57. doi: 10.4088/JCP.09m05154yel.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine or Risperidone + Aripiprazole in people with Schizophrenia and Schizoaffective Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 48 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 2 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 48 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint (time frame: (Week 16) or at time of discontinuation). 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 NCT00325689, 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.