Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder
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ClinicalTrials.gov Identifier: NCT00838227 |
Recruitment Status
:
Withdrawn
(This study was withdrawn because there was no source of funding to implement the study.)
First Posted
: February 6, 2009
Last Update Posted
: September 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: modafinil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
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 : | February 2008 |
Estimated Primary Completion Date : | January 2012 |
Estimated Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: One arm |
Drug: modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
Other Name: Provigil
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- Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB) [ Time Frame: 8 weeks ]
- Sedation and weight changes [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838227
Principal Investigator: | Jean-Pierre Lindenmayer, MD | Manhattan Psychiatric Center |
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 |
First Posted: | February 6, 2009 Key Record Dates |
Last Update Posted: | September 18, 2014 |
Last Verified: | September 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 |