The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity

Major Depressive Disorder Clinical Trial

Official title:

The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205946
• Other study ID #: 2004-P-002234-1
• Secondary ID: 2004-P002234-1
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: December 4, 2007
• Start date: April 2005
• Est. completion date: July 2007

Study information

• Verified date: November 2007
• Source: Affective Neuroscience Laboratory
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL (bupropion hydrochloride) on reward processing.

Description:

A cardinal feature of Major Depressive Disorder is anhedonia, which is a lack of pleasure in normally enjoyable activities. In order to understand reward processing in depressed individuals it is also necessary to study reward processing in people who are not depressed. Bupropion, the active drug in the anti-depressant Wellbutrin XL, has been shown to increase brain reward functioning in animals. The goal of the present study is to investigate the effects of Wellbutrin XL administered to psychiatrically healthy individuals as they perform a computer task known to assess reward processing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse)

• Non-Smoker

• Right-handed (Chapman and Chapman 1987)

• Ability to provide informed consent

Exclusion Criteria:

• Predisposition to seizure (e.g. family history of a seizure disorder, history of head trauma) or current use of medications that lower the seizure threshold

• History or current diagnosis of anorexia or bulimia

• Alcohol or substance abuse within the past year

• Current usage of Wellbutrin or Zyban or other drugs that contain bupropion

• Recent discontinuation of alcohol or sedatives (including benzodiazepines)

• Use of (in the last 2 weeks) medications that may have antidepressant properties (ex. some herbal supplements)

• Known allergies to bupropion

• Currently lactating, pregnant or believe you are likely to be pregnant (enrolled subjects who are not using reliable contraception and have engaged in sexual intercourse since their last menstrual period will be given a self-administered pregnancy test.)

• Left-handed/ambidextrous

• Evidence of neurological illness

• Serious suicide or homicide risk

Concomitant medications other than those listed in the exclusion criteria will be considered on an individual basis. Oral contraceptives will be allowed.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Bupropion
150 mg of bupropion administered 5 hours before fMRI scanning
• Placebo
Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)

Locations

Country	Name	City	State
United States	The Depression Clinical and Research Program, Massachusetts General Hospital	Boston	Massachusetts
United States	Affective Neuroscience Laboratory, Department of Psychology, Harvard University	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Affective Neuroscience Laboratory	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants.		1 day	Yes