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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

February 5, 2009
February 5, 2009
February 2008
January 2012   (final data collection date for primary outcome measure)
Cognitive changes as measured by the NIH MCCB MATRICS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Sedation and weight changes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder
Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study

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
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Cognition
  • Obesity
  • Sedation
Drug: modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
Other Name: Provigil
Not Provided
Turner DC, Clark L, Pomarol-Clotet E, McKenna P, Robbins TW, Sahakian BJ. Modafinil improves cognition and attentional set shifting in patients with chronic schizophrenia. Neuropsychopharmacology. 2004 Jul;29(7):1363-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact: Saurabh Kaushik, MD 646-672-6352 maisskk@omh.state.ny.us
United States
 
NCT00838227
07I/C41-00
Yes
Saurabh Kaushik, MD, Manhattan Psychiatric Center
Manhattan Psychiatric Center
Not Provided
Principal Investigator: Saurabh Kaushik, MD Manhattan Psychiatric Center
Study Director: Jean-Pierre Lindenmayer, MD Manhattan Psychiatric Center
Manhattan Psychiatric Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP