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

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by:
Affective Neuroscience Laboratory
ClinicalTrials.gov Identifier:
NCT00205946
First received: September 13, 2005
Last updated: December 4, 2007
Last verified: November 2007

September 13, 2005
December 4, 2007
April 2005
Not Provided
Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Objective Behavioral Measure of Reward Processing
Complete list of historical versions of study NCT00205946 on ClinicalTrials.gov Archive Site
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The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity

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

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Bupropion
    150 mg of bupropion administered 5 hours before fMRI scanning
    Other Name: Wellbutrin XL
  • Drug: Placebo
    Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Bupropion
    Intervention: Drug: Bupropion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2007
Not Provided

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.

Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205946
2004-P-002234-1, 2004-P002234-1
Yes
Diego Pizzagalli, Principal Investigator, Harvard University
Affective Neuroscience Laboratory
Massachusetts General Hospital
Principal Investigator: Diego A Pizzagalli, PhD Harvard University
Affective Neuroscience Laboratory
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP