Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder
Information source: Manhattan Psychiatric Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Cognition; Obesity; Sedation
Intervention: modafinil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Manhattan Psychiatric Center Official(s) and/or principal investigator(s):
Saurabh Kaushik, MD, Principal Investigator, Affiliation: Manhattan Psychiatric Center
Jean-Pierre Lindenmayer, MD, Study Director, Affiliation: Manhattan Psychiatric Center
Overall contact:
Saurabh Kaushik, MD, Phone: 646-672-6352, Email: maisskk@omh.state.ny.us
Summary
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
Clinical Details
Official title: Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Cognitive changes as measured by the NIH MCCB MATRICS
Secondary outcome: Sedation and weight changes
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Saurabh Kaushik, MD, Phone: 646-672-6352, Email: maisskk@omh.state.ny.us
Manhattan Psychiatric Center, New York, New York 10605, United States; Recruiting
Additional Information
Related publications: Turner DC, Clark L, Pomarol-Clotet E, McKenna P, Robbins TW, Sahakian BJ. Modafinil improves cognition and attentional set shifting in patients with chronic schizophrenia. Neuropsychopharmacology. 2004 Jul;29(7):1363-73.
Starting date: February 2008
Ending date: June 2012
Last updated: February 5, 2009
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