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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Manhattan Psychiatric Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00838227
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study

Resource links provided by NLM:

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:
    Drug: modafinil
    Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
    Other Name: Provigil
  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:

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

Additional relevant MeSH terms:
Obesity
Psychotic Disorders
Schizophrenia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
 Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013