Protocol Number: 08-M-0002

Title:

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

Number:

08-M-0002

Summary:

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

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

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

- Age range: 18-45 years.

- Normal EKG and blood pressure readings.

EXCLUSION CRITERIA:

- Normal volunteers with an active Axis I or Axis II disorder or patients with an Axis I diagnosis other than schizophrenia or schizoaffective disorder obtained either from prior SCID interview in Protocol 95-M-0150 or through a screening interview will be excluded.

-Subjects with a history of cardiovascular disease, liver disease and other serious medical illnesses, and untreated or uncontrolled hypertension will be excluded because of the potential for drug-drug interaction or because of the potential deleterious effect of the drug on the medical condition. An electrocardiogram, blood pressure, pulse rate, toxicological screen, cell blood count and metabolic panel including LFTs will be checked on all subjects prior to participation in the study. Any subject with an electrocardiogram deemed abnormal by a cardiologist or with sustained systolic blood pressure of 150 mmHg or above, diastolic blood pressure of 100 mmHg or above will be excluded from the study.

- Schizophrenic patients taking a COMT inhibitor, any illicit drugs of abuse, or MAO inhibitors will be excluded. Patients taking paroxetine, fluoxetine, bupropion, tricyclic antidepressants, albuterol, modafinil, stimulants or pressor agents will be excluded from the study. No medication will be stopped in order to participate in the study.

- Normal control subjects taking any medication other than occasional NSAID or with recent history of illicit drug or alcohol abuse will be excluded.

- Pregnant women: Women of childbearing potential will undergo a urine pregnancy test the day the study initiates and they will be screened by history for the possibility of pregnancy.

Special Instructions:

Currently Not Provided

Keywords:

Genes

Dorsolateral Prefrontal Cortex

Dopamine

Functional MRI

Neuropsychological Testing

Schizophrenia

Atomoxetine

Cognitive Study

Pharmacogenetics

Normal Volunteers

Catechol-O-methyltransferase

Recruitment Keyword(s):

Schizophrenia

Healthy Volunteer

HV

Condition(s):

Schizophrenia

Working Memory

Cognition

Healthy Volunteers

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Amoxetine

Procedure/Surgery: Functional MRI

Procedure/Surgery: Neuropsychiatric Testing

Supporting Site:

National Institute of Mental Health

Contact(s):

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

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Beracochea D, Cagnard B, Celerier A, le Merrer J, Peres M, Pierard C. First evidence of a delay-dependent working memory-enhancing effect of modafinil in mice. Neuroreport. 2001 Feb 12;12(2):375-8.

Egan MF, Goldberg TE, Kolachana BS, Callicott JH, Mazzanti CM, Straub RE, Goldman D, Weinberger DR. Effect of COMT Val108/158 Met genotype on frontal lobe function and risk for schizophrenia. Proc Natl Acad Sci U S A. 2001 Jun 5;9 (12):6917-22. Epub 2001 May 29.

de Saint Hilaire Z, Orosco M, Rouch C, Blanc G, Nicolaidis S. Variations in extracellular monoamines in the prefrontal cortex and medial hypothalamus after modafinil administration: a microdialysis study in rats. Neuroreport. 2001 Nov 16;1 (16):3533-7.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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