Status:
COMPLETED
Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Cephalon
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00373672
Start Date
August 1 2006
End Date
January 1 2010
Last Update
August 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212