Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Sponsor
Manhattan Psychiatric Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00838227
Collaborator
(none)
0
1
52

Study Details

Study Description

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
Phase 2

Detailed Description

This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
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 :
Feb 1, 2008
Anticipated Primary Completion Date :
Jan 1, 2012
Anticipated Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: One arm

Study withdrawn due to lack of funds.

Drug: modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
Other Names:
  • Provigil
  • Outcome Measures

    Primary Outcome Measures

    1. Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB) [8 weeks]

      Study withdrawn due to lack of funds.

    Secondary Outcome Measures

    1. Sedation and weight changes [8 weeks]

      Study withdrawn due to lack of funds.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Manhattan Psychiatric Center

    Investigators

    • Principal Investigator: Jean-Pierre Lindenmayer, MD, Manhattan Psychiatric Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jean-Pierre Lindenmayer, Study Principal Investigator, Manhattan Psychiatric Center
    ClinicalTrials.gov Identifier:
    NCT00838227
    Other Study ID Numbers:
    • 07I/C41-00
    First Posted:
    Feb 6, 2009
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by Jean-Pierre Lindenmayer, Study Principal Investigator, Manhattan Psychiatric Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2020