Effects of Atomoxetine Treatment in Humans
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stress
Intervention: Placebo (Drug); Atomoxetine (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s): Mehmet Sofuoglu, M.D., Ph.D., Principal Investigator, Affiliation: Yale University
Summary
A total of 18 healthy volunteers will participate in this four-week, within-groups,
double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day
washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or
placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After
receiving medication or placebo for three days, subjects will have a 6-hour laboratory
session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg
maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and
subjective outcome measures will be obtained during the experimental sessions. Subjects will
then have a 4-15 day washout period and will be crossed over to the alternative treatment
for Phase II.
Clinical Details
Official title: Effects of Atomoxetine Treatment in Humans
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Measuring subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers.
Detailed description:
Objective: This pilot study will examine the effects of a norepinephrine reuptake blocker,
atomoxetine, on physiological and subjective responses to physical and psychological models
of stress and oral amphetamine in healthy volunteers. The physical stress model will be the
cold pressor test (CPT) and the psychological stress will be the paced auditory serial
addition task (PASAT).
Our overall hypothesis is that atomoxetine treatment, compared to placebo, will attenuate
the physiological and subjective responses to stress and d-amphetamine.
2. Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.
3. Methodology: A total of 18 healthy volunteers will participate in this four-week,
within-groups, double-blind, placebo-controlled study. The study has two phases separated by
a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg
atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for
4 days. After receiving medication or placebo for three days, subjects will have a 6-hour
laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg
(20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal,
and subjective outcome measures will be obtained during the experimental sessions. Subjects
will then have a 4-15 day washout period and will be crossed over to the alternative
treatment for Phase II.
4. Findings: A total of 10 subjects have completed this study. This study has been
published.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Female and males, age 18 to 45 years
- Current history of good health and normal ECG
- For women: not pregnant as determined by pregnancy screening, nor breast feeding, and
using acceptable birth control methods.
Exclusion Criteria:
- History of heart disease, hypertension, renal or hepatic diseases, glaucoma,
hyperthyroidism, or other medical conditions that the physician investigator deems as
contraindicated for the patient to be in the study
- Current use of psychotropic medication(antidepressants, antipsychotics, or
anxiolytics) and/or diagnosis and treatment for Axis I disorders including major
depression, bipolar affective disorder, schizophrenia and panic disorder within the
past year.
- Current dependence on alcohol or on drugs or treatment for drug or alcohol
addiction(amphetamines have greater abuse liability among those with drug addictions)
within the past 5 years.
Locations and Contacts
Additional Information
Starting date: June 2006
Last updated: July 24, 2012
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