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

Northwestern University58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

armodafinil (Nuvigil)DRUG

armodafinil (Nuvigil)150 mg qd

placeboDRUG

identical in appearance to active comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score

For the AX-CPT, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.

Time frame: Baseline and week 6

Data from ClinicalTrials.gov

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