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This study has been withdrawn prior to enrollment.
(This study was withdrawn because there was no source of funding to implement the study.)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

February 5, 2009
September 16, 2014
February 2008
January 2012   (final data collection date for primary outcome measure)
Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Cognitive changes as measured by the NIH MCCB MATRICS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00838227 on ClinicalTrials.gov Archive Site
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
Drug: modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
Other Name: Provigil
Experimental: One arm
Intervention: Drug: modafinil
Saavedra-Velez C, Yusim A, Anbarasan D, Lindenmayer JP. Modafinil as an adjunctive treatment of sedation, negative symptoms, and cognition in schizophrenia: a critical review. J Clin Psychiatry. 2009 Jan;70(1):104-12. Epub 2008 Nov 18. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00838227
07I/C41-00
Yes
Jean-Pierre Lindenmayer, Manhattan Psychiatric Center
Manhattan Psychiatric Center
Not Provided
Principal Investigator: Jean-Pierre Lindenmayer, MD Manhattan Psychiatric Center
Manhattan Psychiatric Center
September 2014

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