Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia
Lead Sponsor:
Cephalon
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of...
Detailed Description
This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy...
Eligibility Criteria
Inclusion
- Key
- The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness.
- Documentation that 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 that antipsychotic medication for at least 4 weeks prior to the screening visit.
- The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
- Women of childbearing potential (not surgically sterile or 2 years postmenopausal) 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. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.
- The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits.
- Key
Exclusion
- The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale.
- The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study.
- The patient has moderate to severe depressive symptoms, as indicated by the CDSS.
- The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
- The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
- The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.
- The patient is a pregnant or lactating woman.
- The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00772005
Start Date
September 1 2008
End Date
May 1 2010
Last Update
July 27 2012
Active Locations (39)
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1
K and S Professional Research Services, LLC
Little Rock, Arkansas, United States, 72201
2
Omega Clinical Trials
Anaheim, California, United States, 92805
3
Synergy Clinical Research Center
Escondido, California, United States, 92025
4
Collaborative NeuroScience
Garden Grove, California, United States, 92845