NCT00573417

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: North Suffolk Mental Health Association · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 1. Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs. 2. Evaluate the effect size of modafinil compared to placebo upon wakefulness and fatigue using the Epworth Sleepiness Scale (ESS) and the Fatigue Severity Scale (FSS). 3. Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score. 4. Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests. 5. Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids. 6. Effect the variability of response in placebo and modafinil groups for each of the outcome measures.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	modafinil	modafinil 100mg tablets. dose excalation up to 300mg
DRUG	Placebo

Timeline

• Start date: 2003-09-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-12-14
• Last updated: 2009-08-12

Locations

1 site across 1 country: United States