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

August 11, 2009 updated by: North Suffolk Mental Health Association
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Freedom Trail Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo
Experimental: modafinil
modafinil 100mg, 200mg, or 300mg (dose escalation)
Drug: modafinil
modafinil 100mg tablets. dose excalation up to 300mg
Other Names:
  • Provigil

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.
Time Frame: 8 weeks
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
8 weeks
Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.
Time Frame: 8 Weeks
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
8 weeks
Effect the variability of response in placebo and modafinil groups for each of the outcome measures.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Suffolk Mental Health Association

Collaborators

Cephalon

Investigators

  • Principal Investigator: Donald Goff, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2009

Last Update Submitted That Met QC Criteria

August 11, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34-02
  • Cephalon 670 Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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