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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-01-31

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.

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Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Armodafinil (Nuvigil)

First group will be randomized to take Armodafinil (Nuvigil) 150 mg, along with their current anti psychotic medication 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.

Group Type ACTIVE_COMPARATOR

armodafinil (Nuvigil)

Intervention Type DRUG

armodafinil (Nuvigil)150 mg qd

Placebo

Second group will be randomized to take placebo,identical in appearance to active comparator, along with their current anti psychotic medication 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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

identical in appearance to active comparator

Interventions

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armodafinil (Nuvigil)

armodafinil (Nuvigil)150 mg qd

Intervention Type DRUG

placebo

identical in appearance to active comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women age 18-65 years
* Patients with Diagnostic and Statistical Manual (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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No