Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: armodafinil (Nuvigil) (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
William V Bobo, M.D., Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Kara L Watts, M.A., Phone: 615-343-9717, Email: kara.l.watts@vanderbilt.edu
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: cognition
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kara L Watts, M.A., Phone: 615-343-9717, Email: kara.l.watts@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37212, United States; Recruiting
Kara L Watts, M.A., Phone: 615-343-9717, Email: kara.l.watt@vanderbilt.edu
William V Bobo, M.D., Phone: 615-327-7049, Email: william.bobo@vanderbilt.edu
William V Bobo, M.D., Principal Investigator
Additional Information
Starting date: August 2006
Ending date: August 2009
Last updated: June 25, 2008
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