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