Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

This study is currently recruiting participants.

Verified by Manhattan Psychiatric Center, February 2009

First Received: February 5, 2009 No Changes Posted

Sponsor:	Manhattan Psychiatric Center
Information provided by:	Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:	NCT00838227

Purpose

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

Condition	Intervention	Phase
Schizophrenia Cognition Obesity Sedation	Drug: modafinil	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity Schizophrenia

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:

Cognitive changes as measured by the NIH MCCB MATRICS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sedation and weight changes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838227

Contacts

Contact: Saurabh Kaushik, MD

646-672-6352

maisskk@omh.state.ny.us

Locations

United States, New York
Manhattan Psychiatric Center	Recruiting
New York, New York, United States, 10605

Sponsors and Collaborators

Manhattan Psychiatric Center

Investigators

Principal Investigator:	Saurabh Kaushik, MD	Manhattan Psychiatric Center
Study Director:	Jean-Pierre Lindenmayer, MD	Manhattan Psychiatric Center

More Information

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.

Responsible Party:	Manhattan Psychiatric Center ( Saurabh Kaushik, MD )
Study ID Numbers:	07I/C41-00
Study First Received:	February 5, 2009
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00838227 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obesity
Physiological Effects of Drugs
Overweight
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Modafinil
Schizophrenia

Body Weight
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Nutrition Disorders
Psychotic Disorders
Overnutrition
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010