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

Sponsor:	North Suffolk Mental Health Association
Collaborator:	Cephalon
Information provided by:	North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:	NCT00573417

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Modafinil Clozapine

U.S. FDA Resources

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
modafinil: Experimental modafinil 100mg, 200mg, or 300mg (dose escalation)	Drug: modafinil modafinil 100mg tablets. dose excalation up to 300mg
placebo: Placebo Comparator 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.

Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.
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).
Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.
Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids.
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

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

Responsible Party:	Massachusetts General Hospital ( Donald Goff, MD )
Study ID Numbers:	34-02, Cephalon 670 Study
Study First Received:	December 13, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00573417 History of Changes
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:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Central Nervous System Stimulants
Antipsychotic Agents
Protective Agents
Neuroprotective Agents
Modafinil

Pharmacologic Actions
Schizophrenia
GABA Antagonists
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Clozapine
GABA Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009