Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder

Study Overview
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Brief Summary
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This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.

Official Title
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Effect of Addition of Modafinil on the Tolerability and Efficacy for Cognition of Atypical Antipsychotic Drugs in Patients With Schizophrenia or Schizoaffective Disorder

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: armodafinil (Nuvigil)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Men and women age 18-65 years Patients with DSM-IV defined schizophrenia or schizoaffective disorder Treated with any atypical antipsychotic for at least 2 months Patients with documented weight gain > 7% with current antipsychotic medication Able to provide written consent Exclusion criteria Women who are pregnant or nursing. Female participants must have a negative urine pregnancy test at screening. DSM-IV defined substance or alcohol dependence within the 2 months preceding the start of the trial Treatment with a monoamine oxidase inhibitor (e.g., tranylcypromine, phenelzine, isocarboxazid) within 2 weeks of starting the trial Patients considered at high risk for suicide or violence Patients with history of or symptoms on systems review consistent with clinically significant and currently relevant hematologic, renal, hepatic, gastrointestinal, endocrine, pulmonary, dermatologic, oncologic or neurologic (including seizures or epilepsy) disease Patients with a history of or symptoms on systems review consistent with significant cardiovascular disease, bypass surgery, or concurrent cardiovascular disease, including uncontrolled hypertension, hypotension, congestive heart failure, angina pectoris, or recent (within last 6 months) myocardial infarction Use of any investigational drug within 4 weeks before screening History of hypersensitivity or other intolerable adverse effects to modafinil Patients who experience severe sleep disturbances from modafinil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>armodafinil (Nuvigil) 150 mg | Drug: armodafinil (Nuvigil)<br>* armodafinil (Nuvigil)150 mg qd<br>|
| Placebo Comparator: 2<br>identical in appearance to active comparator | Drug: placebo<br>* identical in appearance to active comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognition |  | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, cognition