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

North Suffolk Mental Health Association

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: modafinil; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00573417

Cephalon 670 Study

34-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

modafinil

Experimental group

Description:

modafinil 100mg, 200mg, or 300mg (dose escalation)

Treatment:

Drug: modafinil

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo