A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
This study has been completed.
Sponsor:
North Suffolk Mental Health Association
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
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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.
- 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 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 Schizophrenia and Disorders with Psychotic Features Mental Disorders Clozapine Modafinil Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents Central Nervous System Stimulants Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013