A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Completed · Phase 4 · Has a placebo group
Conditions studied: Schizophrenia
In brief
This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.
Key facts
- Study ID
- NCT00573417
- Run by
- North Suffolk Mental Health Association
- People needed
- 40
- Starts
- 2003-09-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2009-08-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
- Ages 18-65 years
- Capable of providing informed consent, or capable of providing assent with a guardian who provides informed consent
- Stable dose of clozapine for at least 1 month
- Three months of stable psychotic symptoms
You may not qualify if…
- Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
- Current substance abuse
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
- Unable to complete neuropsychological tests
- History of serious blood dyscrasia requiring discontinuation of clozapine
- Serious suicidal or homicidal risk within the past six months
- Current treatment with a psychostimulant
Where it is running
- Freedom Trail Clinic — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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