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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)
BG 10-CRC RM 7-3342
10 CENTER DR
BETHESDA MD 20814
(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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