Protocol Details

Randomized, Double-Blinded, Placebo Controlled Study of the Effects of Tolcapone and Entacapone 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	02-M-0239
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; Clinical Trial; fMRI; PFC; Vitamin B2; Riboflavin; Tolcapone; Placebo; Normal Volunteers
Recruitment Keyword(s)	Schizophrenia; Healthy Volunteers; HV; Vitamin B2; Riboflavin
Condition(s)	Schizophrenia
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	Drug: Tolcapone
Supporting Site	National Institute of Mental Health

This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as well as patients with schizophrenia. Atomoxetine is a drug that has been FDA approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain.

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Eligibility

INCLUSION CRITERIA:

1) Prior participation under NIH protocol number 95-M-0150, or new normal volunteers or schizophrenic patients that meet criteria for NIH protocol number 95-M-0150.

2) No Axis I or Axis II diagnosis in normal volunteers.

3) Age range: 18-50 years.

EXCLUSION CRITERIA:

1) Normal volunteers with an Axis I or Axis II disorder obtained either from prior SCID interview in Protocol 95-M-0150 or through a screening interview will be excluded.

2) Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, and untreated or uncontrolled hypertension will be excluded. An electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will be checked on all subjects prior to participation in the study. Individuals with persistent tardive dyskinesia or abnormal LFTs, or individuals with significant history of alcoholism or liver enzyme elevation will be excluded from the study.

3) Schizophrenic patients taking clozapine, a COMT inhibitor, any illicit drugs of abuse, or MAO inhibitors will be excluded.

4) Normal control subjects taking any medications other than occasional NSAI will be excluded.

5) Pregnant 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.

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Citations:

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.

Arnsten AF. Catecholamine regulation of the prefrontal cortex. J Psychopharmacol. 1997;11(2):151-62.

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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	Joann Berkson, R.N. National Institute of Mental Health (NIMH) National Institutes of Health Building 10 Room 3C-432B 10 Center Drive Bethesda, Maryland 20892 (301) 451-0167 Email: Not Specified	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:

NCT00044083

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