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| Sponsors and Collaborators: |
Bristol-Myers Squibb Otsuka America Pharmaceutical |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00080327 |
Purpose
A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Aripiprazole Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia |
| Estimated Enrollment: | 370 |
| Study Start Date: | November 2003 |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Aripiprazole
Tablets, Oral, 2mg, Once daily, 6 weeks.
|
| 2: Active Comparator |
Drug: Aripiprazole
Tablets, Oral, 5mg, Once daily, 6 weeks.
|
| 3: Active Comparator |
Drug: Aripiprazole
Tablets, Oral, 10mg, Once daily, 6 weeks.
|
| 4: Placebo Comparator |
Drug: Placebo
Tablets, Oral, 0mg, Once daily, 6 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CN138-113 ST |
| Study First Received: | March 26, 2004 |
| Last Updated: | August 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00080327 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Schizophrenia Tranquilizing Agents Mental Disorders Psychotropic Drugs Central Nervous System Depressants |
Psychotic Disorders Aripiprazole Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
|
Schizophrenia Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Aripiprazole Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |