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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT00838227
Recruitment Status : Withdrawn (This study was withdrawn because there was no source of funding to implement the study.)
First Posted : February 6, 2009
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Jean-Pierre Lindenmayer, Manhattan Psychiatric Center

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: modafinil Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study
Study Start Date : February 2008
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: One arm Drug: modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
Other Name: Provigil


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Sedation and weight changes [ Time Frame: 8 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic and Statistical Manual-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 monoamine oxidase 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838227


Sponsors and Collaborators
Manhattan Psychiatric Center
Investigators
Principal Investigator: Jean-Pierre Lindenmayer, MD Manhattan Psychiatric Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Jean-Pierre Lindenmayer, Study Principal Investigator, Manhattan Psychiatric Center
ClinicalTrials.gov Identifier: NCT00838227     History of Changes
Other Study ID Numbers: 07I/C41-00
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Jean-Pierre Lindenmayer, Manhattan Psychiatric Center:
Schizophrenia
Cognition
Obesity
Sedation

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Modafinil
Armodafinil
 Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs