A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
modafinil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Clozapine, Cognition, Metabolic Syndrome, Negative Symptoms, Wakefulness, Fatigue
Eligibility 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
Sites / Locations
- Freedom Trail Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
modafinil
placebo
Arm Description
modafinil 100mg, 200mg, or 300mg (dose escalation)
placebo
Outcomes
Primary Outcome Measures
Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
Secondary Outcome Measures
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 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.
Full Information
NCT ID
NCT00573417
First Posted
December 13, 2007
Last Updated
August 11, 2009
Sponsor
North Suffolk Mental Health Association
Collaborators
Cephalon
1. Study Identification
Unique Protocol Identification Number
NCT00573417
Brief Title
A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Official Title
A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
North Suffolk Mental Health Association
Collaborators
Cephalon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Clozapine, Cognition, Metabolic Syndrome, Negative Symptoms, Wakefulness, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modafinil
Arm Type
Experimental
Arm Description
modafinil 100mg, 200mg, or 300mg (dose escalation)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
modafinil
Other Intervention Name(s)
Provigil
Intervention Description
modafinil 100mg tablets. dose excalation up to 300mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.
Time Frame
8 weeks
Title
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
Title
Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.
Time Frame
8 Weeks
Title
Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids.
Time Frame
8 weeks
Title
Effect the variability of response in placebo and modafinil groups for each of the outcome measures.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Goff, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freedom Trail Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19689921
Citation
Freudenreich O, Henderson DC, Macklin EA, Evins AE, Fan X, Cather C, Walsh JP, Goff DC. Modafinil for clozapine-treated schizophrenia patients: a double-blind, placebo-controlled pilot trial. J Clin Psychiatry. 2009 Dec;70(12):1674-80. doi: 10.4088/JCP.08m04683. Epub 2009 Aug 11.
Results Reference
derived
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A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
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