NIH Clinical Research Studies

Protocol Number: 03-M-0143

Active Accrual, Protocols Recruiting New Patients

Title:
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
Number:
03-M-0143
Summary:
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

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. 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: 18-60 years.

EXCLUSION CRITERIA:

Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, current active substance abuse, and untreated or uncontrolled hypertension will be excluded. Individuals with persistent tardive dyskinesia or abnormal LFTs 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)

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

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):
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.

Active Accrual, Protocols Recruiting New Patients

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