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OpenTrials
Completed

NCT Number: NCT00373672

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

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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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

armodafinil (Nuvigil)

Drug

armodafinil (Nuvigil)150 mg qd

Placebo

Drug

identical in appearance to active comparator

Primary outcomes

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

    Time frame: Baseline and week 6

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Cephalon
  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 8, 2006
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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