Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder



Status:Completed
Conditions:Cognitive Studies, Obesity Weight Loss, Schizophrenia, Hospital, Psychiatric
Therapuetic Areas:Endocrinology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 64
Updated:11/8/2014
Start Date:February 2008
End Date:June 2012
Contact:Saurabh Kaushik, MD
Email:maisskk@omh.state.ny.us
Phone:646-672-6352

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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study

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


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.
We found this trial at
1
site
New York, New York 10035
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mi
from
New York, NY
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