A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Information source: North Suffolk Mental Health Association
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: modafinil (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: North Suffolk Mental Health Association Official(s) and/or principal investigator(s): Donald Goff, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Freedom Trail Clinic, Boston, Massachusetts 02114, United States
Additional Information
Starting date: September 2003
Last updated: August 11, 2009
|