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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00772005 |
The primary objective of the study is to evaluate whether armodafinil is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the symptoms of schizophrenia
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: armodafinil Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/Day) as Adjunctive Therapy in Adults With Schizophrenia |
Estimated Enrollment: | 280 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
150 mg/day armodafinil
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Drug: armodafinil
150 mg/day armodafinil
|
2: Active Comparator
200 mg/day armodafinil
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Drug: armodafinil
200 mg/day armodafinil
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3: Active Comparator
250 mg/day armodafinil
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Drug: armodafinil
250 mg/day armodafinil
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4: Placebo Comparator
Matching Placebo
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Drug: placebo
placebo
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: Cephalon Contact | 1-877-CEPHTRY |
Study Director: | Sponsor's Medical Expert | Cephalon |
Responsible Party: | Cephalon ( Sponsor's Medical Expert ) |
Study ID Numbers: | C10953/2034/SZ/MN |
Study First Received: | October 10, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772005 |
Health Authority: | United States: Food and Drug Administration |
Schizophrenia Mental Disorders Psychotic Disorders Modafinil Schizophrenia and Disorders with Psychotic Features |
Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |