Effects of Atomoxetine Treatment in Humans

NCT00611936 | Completed Phase 1 DMC

• 1 other identifier: 0605001441
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stress

Keywords

Atomoxetine; Stress; d-amphetamine

Outcome Measures

Primary Outcomes (1)

• Measuring subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers.

  one year

Study Arms (2)

2

PLACEBO COMPARATOR

Second arm is placebo

Drug: Placebo

1

EXPERIMENTAL

One arm is atomoxetine 40 mg per day

Drug: Atomoxetine

Interventions

Placebo DRUG

Placebo

2

Atomoxetine DRUG

20mg maximum of d-amphetamine

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• US Department of Veterans Affairs: collaborator

MeSH Terms

Interventions

Atomoxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: June 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2009
• Last Updated: July 25, 2012

Record last verified: 2012-07