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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine or Risperidone + Aripiprazole | Active Comparator |
| |
| Quetiapine or Risperidone + placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine or Risperidone + Aripiprazole | Drug | Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint | (Week 16) or at time of discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S) | at endpoint (Week 16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K & S Professional Research Services, Llc | Little Rock | Arkansas | 72201 | United States | ||
| Comprehensive Neuroscience, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19906340 | Background | 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. |
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|
| Quetiapine or Risperidone + placebo | Drug | Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks. |
|
| Cerritos |
| California |
| 90703 |
| United States |
| Atp Clinical Research, Inc. | Costa Mesa | California | 92626 | United States |
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | United States |
| San Fernando Mental Health Center | Granada Hills | California | 91344 | United States |
| Uci Medical Center | Orange | California | 92868 | United States |
| California Clinical Trials Medical Group | Paramount | California | 90723 | United States |
| California Clinical Trials | San Diego | California | 92123 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | United States |
| California Neuropsychopharmacology Clinical Research Inst. | San Diego | California | 92126 | United States |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | United States |
| Department Of Psychiatry And Behavioral Sciences | Stanford | California | 94305 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| University Of Colorado At Denver And Health Sciences Center | Denver | Colorado | 80220 | United States |
| Institute Of Living | Hartford | Connecticut | 06106 | United States |
| Behavioral Clinical Research, Inc | North Miami | Florida | 33161 | United States |
| Uptown Research Institute, Llc | Chicago | Illinois | 60640 | United States |
| Alexian Center For Psychiatric Research | Hoffman Estates | Illinois | 60194 | United States |
| Indiana University School Of Medicine | Indianapolis | Indiana | 46202 | United States |
| Lsu Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| J. Gary Booker, Md | Shreveport | Louisiana | 71104 | United States |
| Sheppard Pratt Health System | Baltimore | Maryland | 21285 | United States |
| North Suffolk Mental Health Association | Boston | Massachusetts | 02114 | United States |
| Community Counseling Of Bristol County, Inc. (Ccbc) | Taunton | Massachusetts | 02780 | United States |
| University Of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Cri Worldwide, Llc | Clementon | New Jersey | 08021 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Advanced Bio-Behavioral Sciences | Elmsford | New York | 10523 | United States |
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| Manhattan Psychiatric Center | New York | New York | 10035 | United States |
| Strong Ties Community Support Program | Rochester | New York | 14623 | United States |
| Behavioral Medical Research Of Staten Island | Staten Island | New York | 10305 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| Saroj B. Brar, M.D., Inc. | Cleveland | Ohio | 44113 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | United States |
| Department Of Veterans Affairs Medical Center | Coatesville | Pennsylvania | 19320 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Va Medical Center (116a) | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Belmont Center For Comprehensive Treatment | Philadelphia | Pennsylvania | 19131 | United States |
| Cri Worldwide, Llc | Philadelphia | Pennsylvania | 19149 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Medlabs Research Of Houston, Inc. | Houston | Texas | 77057 | United States |
| University Of Texas Health Science Center At San Antonio | San Antonio | Texas | 78229 | United States |
| Va Puget Sound Health Care System | Tacoma | Washington | 98493 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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