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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2007

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.

Interventions

  • Drug: modafinil
    • modafinil 100mg tablets. dose excalation up to 300mg
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: modafinil
    • modafinil 100mg, 200mg, or 300mg (dose escalation)
  • Placebo Comparator: placebo
    • placebo

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
    • Time Frame: 8 weeks

Secondary Measures

  • Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.
    • Time Frame: 8 weeks
  • 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).
    • Time Frame: 8 weeks
  • Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.
    • Time Frame: 8 Weeks
  • Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids.
    • Time Frame: 8 weeks
  • Effect the variability of response in placebo and modafinil groups for each of the outcome measures.
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • North Suffolk Mental Health Association
  • Collaborator
    • Cephalon
  • Provider of Information About this Clinical Study
    • Donald Goff, MD, Massachusetts General Hospital
  • Overall Official(s)
    • Donald Goff, MD, Principal Investigator, Massachusetts General Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.