The Effects of Atomoxetine on Cognition and Brain Function Based on COMT Genotype

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00548327
• Date of registration: 19/10/2007
• Primary sponsor: National Institute of Mental Health (NIMH)
• Public title: The Effects of Atomoxetine on Cognition and Brain Function Based on COMT Genotype
• Scientific 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
• Date of first enrolment: October 2007
• Target sample size: 11
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00548327
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jose A Apud, M.D.
• Affiliation: National Institute of Mental Health (NIMH)

Key inclusion & exclusion 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. Normal controls on
contraceptive medication will be excluded from the study.

- 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cognition

Healthy Volunteers

Schizophrenia

Working Memory

Intervention(s)

Drug: Amoxetine

Procedure: Functional MRI

Procedure: Neuropsychiatric Testing

Primary Outcome(s)

Changes in cognitive function [Time Frame: No]

Secondary Outcome(s)

Changes in Psychopathology Rating Scale Scores [Time Frame: Yes]

Secondary ID(s)

08-M-0002

080002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors