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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This study has been withdrawn prior to enrollment.
(This study was withdrawn because there was no source of funding to implement the study.)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:
Manhattan Psychiatric Center
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
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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: | 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:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
U.S. FDA Resources
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00838227
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 |
Keywords provided by Jean-Pierre Lindenmayer, Manhattan Psychiatric Center:
|
Schizophrenia Cognition Obesity Sedation |
Additional relevant MeSH terms:
|
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Modafinil Armodafinil |
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 |
ClinicalTrials.gov processed this record on July 21, 2017