Protocol Details

Randomized, Double-Blinded, Placebo Controlled Study of the Effects of Modafinil on Cognitive Function in Patients with Schizophrenia and Normal Controls Based on COMT Genotype

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	03-M-0143
Sponsoring Institute	National Institute of Mental Health (NIMH)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: 50
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Catecholamines; Dopamine; fMRI; Working Memory; Clinical Trial; Stabilization; Inpatients; Placebo; Modafinil; Normal Volunteers
Recruitment Keyword(s)	Schizophrenia; Schizoaffective Disorder; Healthy Volunteer; HV
Condition(s)	Schizophrenia; Schizoaffective Disorder
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	Drug: Modafinil Procedure/Surgery: Functional MRI Procedure/Surgery: Neuropsychological Testing
Supporting Site	National Institute of Mental Health

This study will evaluate whether modafinil improves cognition in patients with schizophrenia and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain

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Eligibility

INCLUSION CRITERIA:

Prior participation under NIH protocol # 95-M-0150, or new normal volunteers. Patients with Schizophrenia or Schizoaffective disorder that meet criteria for NIH protocol # 95-M-0150 will be included.

No active Axis I or Axis II diagnosis in normal volunteers.

Age range: 18-50 years.

EXCLUSION CRITERIA:

Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, current active substance abuse or history of substance abuse for more than 5 years, and untreated or uncontrolled hypertension will be excluded. Individuals with persistent tardive dyskinesia will be excluded from the study. An electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will be checked on all subjects prior to participation in the study.

Schizophrenic patients taking, a COMT inhibitor, buproprion, stimulants, other cognitive enhancers or any illicit drugs of abuse, or MAO inhibitors will be excluded.

Normal control subjects taking any medications affecting brain function will be excluded.

Pregnant or breastfeeding women. Women of childbearing potential will undergo a urine pregnancy test the day the study initiates and screened by history for the possibility of pregnancy.

Patients with significant history of violence against self or others as established in protocol # 89-M-0160 (Inpatient Evaluation of Neuropsychiatric Patients)

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Citations:

Aguirre JA, Cintra A, Hillion J, Narvaez JA, Jansson A, Antonelli T, Ferraro L, Rambert FA, Fuxe K. A stereological study on the neuroprotective actions of acute modafinil treatment on 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-induced nigral lesions of the male black mouse. Neurosci Lett. 1999 Nov 19;275(3):215-8.

Aksoy S, Klener J, Weinshilboum RM. Catechol-O-methyltransferase pharmacogenetics: photoaffinity labelling and western blot analysis of human liver samples. Pharmacogenetics. 1993 Apr;3(2):116-22.

Andreasen NC, Arndt S, Cizadlo T, O'Leary DS, Watkins GL, Ponto LL, Hichwa RD. Sample size and statistical power in [15O]H2O studies of human cognition. J Cereb Blood Flow Metab. 1996 Sep;16(5):804-16.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Jose A. Apud, M.D. National Institute of Mental Health (NIMH) National Institutes of Health 10 CENTER DR BLDG 10 CRC-7 3342 MSC 1379 BETHESDA MD 20892 (301) 594-6561 apudj@mail.nih.gov	Jose A. Apud, M.D. National Institute of Mental Health (NIMH) National Institutes of Health 10 CENTER DR BLDG 10 CRC-7 3342 MSC 1379 BETHESDA MD 20892 (301) 594-6561 apudj@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00057707

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