Trial record 1 of 1 for:    NCT00573417
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A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by:
North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00573417
First received: December 13, 2007
Last updated: August 11, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: modafinil
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:
  • Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Effect the variability of response in placebo and modafinil groups for each of the outcome measures. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: modafinil
modafinil 100mg, 200mg, or 300mg (dose escalation)
Drug: modafinil
modafinil 100mg tablets. dose excalation up to 300mg
Other Name: Provigil
Placebo Comparator: placebo
placebo
Drug: Placebo

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573417

Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
Cephalon
Investigators
Principal Investigator: Donald Goff, MD Massachusetts General Hospital
  More Information

No publications provided by North Suffolk Mental Health Association

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donald Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00573417     History of Changes
Other Study ID Numbers: 34-02, Cephalon 670 Study
Study First Received: December 13, 2007
Last Updated: August 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:
Schizophrenia
Clozapine
Cognition
Metabolic Syndrome
Negative Symptoms
Wakefulness
Fatigue

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Armodafinil
Clozapine
Modafinil
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 23, 2014