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This study has been withdrawn prior to enrollment.

(This study was withdrawn because there was no source of funding to implement the study.)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

History of Changes

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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

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 (Adult)
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:

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.


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:


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 September 23, 2016

To Top