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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

This study has been withdrawn prior to enrollment.
(This study was withdrawn because there was no source of funding to implement the study.)
Information provided by (Responsible Party):
Jean-Pierre Lindenmayer, Manhattan Psychiatric Center Identifier:
First received: February 5, 2009
Last updated: September 16, 2014
Last verified: September 2014
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 Drug: modafinil Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Jean-Pierre Lindenmayer, Manhattan Psychiatric Center:

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

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

Enrollment: 0
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)
Arms Assigned Interventions
Experimental: One arm Drug: modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
Other Name: Provigil


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

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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Please refer to this study by its identifier: NCT00838227

Sponsors and Collaborators
Manhattan Psychiatric Center
Principal Investigator: Jean-Pierre Lindenmayer, MD Manhattan Psychiatric Center
  More Information

Responsible Party: Jean-Pierre Lindenmayer, Study Principal Investigator, Manhattan Psychiatric Center Identifier: NCT00838227     History of Changes
Other Study ID Numbers: 07I/C41-00
Study First Received: February 5, 2009
Last Updated: September 16, 2014

Keywords provided by Jean-Pierre Lindenmayer, Manhattan Psychiatric Center:

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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 processed this record on September 21, 2017