A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Suffolk Mental Health Association
• Collaborator: Cephalon
• Treatments: Armodafinil; Clozapine; Modafinil

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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