Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
NCT ID: NCT00487942
Last Updated: 2013-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-07-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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50 mg/day armodafinil
Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 50 mg/day armodafinil treatment arm for the double-blind treatment period of the study took one 50 mg armodafinil tablet plus three placebo tablets each morning.
armodafinil
50 mg/day armodafinil
100 mg/day armodafinil
Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 100 mg/day armodafinil treatment arm for the double-blind treatment period of the study took two 50 mg armodafinil tablets plus two placebo tablets each morning. Subjects began taking 50 mg/day and then titrated to 100 mg/day on Day 2 of the first week of the double-blind treatment period.
armodafinil
100 mg/day armodafinil
200 mg/day armodafinil
Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 200 mg/day armodafinil treatment arm for the double-blind treatment period of the study took four 50 mg armodafinil tablet and no placebo tablets each morning. Subjects were titrated to this dose by starting treatment at 50 mg/day (1 tablet) and increasing by 50 mg increments on days 2, 4, and 6 until they were taking 200 mg/day.
armodafinil
200 mg/day armodafinil
Placebo
Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the placebo treatment arm for the double-blind treatment period of the study took four placebo tablets and no armodafinil tablets each morning.
placebo
placebo
Interventions
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armodafinil
50 mg/day armodafinil
armodafinil
100 mg/day armodafinil
armodafinil
200 mg/day armodafinil
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* The patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. The patient is prepared to remain at these stable dosages for the duration of the study.
* The patient is a man or woman 18 through 60 years of age.
* The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis.
* Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
* The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.
Exclusion Criteria
* The patient has tardive dyskinesia or any other clinically significant movement disorder.
* The patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
* The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
18 Years
60 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Cephalon
Locations
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Collaborative NeuroScience Network
Garden Grove, California, United States
Synergy Clinical Research
National City, California, United States
California Clinical Trials
Paramount, California, United States
CNRI-Los Angeles, LLC
Pico Rivera, California, United States
CNRI-San Diego
San Diego, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Atlanta Center for Clinical Research
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke Department of Psychiatry - DUMC
Durham, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
University Hills Clinical Research
Irving, Texas, United States
Countries
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References
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Kane JM, D'Souza DC, Patkar AA, Youakim JM, Tiller JM, Yang R, Keefe RS. Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study. J Clin Psychiatry. 2010 Nov;71(11):1475-81. doi: 10.4088/JCP.09m05950gry. Epub 2010 Aug 24.
Other Identifiers
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C10953/2033/SZ/US
Identifier Type: -
Identifier Source: org_study_id
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