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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This study has been withdrawn prior to enrollment.
(This study was withdrawn because there was no source of funding to implement the study.)
Sponsor:
Information provided by (Responsible Party):
Jean-Pierre Lindenmayer, Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00838227
First received: February 5, 2009
Last updated: September 16, 2014
Last verified: September 2014
  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
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:


Further study details as provided by Manhattan Psychiatric Center:

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Manhattan Psychiatric Center
Investigators
Principal Investigator: Jean-Pierre Lindenmayer, MD Manhattan Psychiatric Center
  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
Study First Received: February 5, 2009
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Manhattan Psychiatric Center:
Schizophrenia
Cognition
Obesity
Sedation

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 19, 2014