View Clinical Trial (Medical Research Study)
Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10605 |
| Conditions: |
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Schizophrenia - Cognition - Obesity - Sedation |
| Purpose: |
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This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable
antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in
patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent,
will lead to improved cognition, increased wakefulness, and decreased weight in patients
with schizophrenia who are on stable antipsychotic regimens
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three
years
- Auditory and visual acuity adequate to complete cognitive tests
- Stable dose of antipsychotics for at least 2 weeks prior to entry
- Good physical health determined by complete physical examination, laboratory tests,
and EKG
- Capacity and willingness to give written informed consent.
Exclusion Criteria:
- Inability to read or speak English
- Documented disease of the central nervous system
- History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g.
mental retardation)
- Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal,
pulmonary or hematologic conditions;
- HIV positive
- Patients on antidepressants, including MAO inhibitors
- Uncontrolled hypertension
- Pregnancy
- Patients with a current diagnosis of substance dependence
- Significant history of violence
- History of an eating disorder
- Ready for discharge within the following 8 weeks.
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| NCT ID: |
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NCT00838227 |
| Primary Contact: |
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Principal Investigator
Saurabh Kaushik, MD
Manhattan Psychiatric Center
Saurabh Kaushik, MD
Phone: 646-672-6352
Email: maisskk@omh.state.ny.us
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10605
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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