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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373672
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : February 23, 2010
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Vanderbilt University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: armodafinil (Nuvigil) Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Addition of Modafinil on the Tolerability and Efficacy for Cognition of Atypical Antipsychotic Drugs in Patients With Schizophrenia or Schizoaffective Disorder
Study Start Date : August 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Armodafinil

Arm Intervention/treatment
Active Comparator: 1
armodafinil (Nuvigil) 150 mg
Drug: armodafinil (Nuvigil)
armodafinil (Nuvigil)150 mg qd

Placebo Comparator: 2
identical in appearance to active comparator
Drug: placebo
identical in appearance to active comparator

Primary Outcome Measures :
  1. cognition [ Time Frame: six weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373672

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
National Alliance for Research on Schizophrenia and Depression
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Principal Investigator: William V Bobo, M.D. Vanderbilt University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center Identifier: NCT00373672    
Other Study ID Numbers: 060567
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: February 23, 2010
Last Verified: February 2010
Keywords provided by Vanderbilt University:
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action