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
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: Bupropion
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity

Resource links provided by NLM:


Further study details as provided by Affective Neuroscience Laboratory:

Primary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: April 2005
Study Completion Date: July 2007
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)
Active Comparator: Bupropion Drug: Bupropion
150 mg of bupropion administered 5 hours before fMRI scanning
Other Name: Wellbutrin XL

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205946

Locations
United States, Massachusetts
The Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Affective Neuroscience Laboratory, Department of Psychology, Harvard University
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Affective Neuroscience Laboratory
Massachusetts General Hospital
Investigators
Principal Investigator: Diego A Pizzagalli, PhD Harvard University
  More Information

No publications provided

Responsible Party: Diego Pizzagalli, Principal Investigator, Harvard University
ClinicalTrials.gov Identifier: NCT00205946     History of Changes
Other Study ID Numbers: 2004-P-002234-1, 2004-P002234-1
Study First Received: September 13, 2005
Last Updated: December 4, 2007
Health Authority: United States: Federal Government

Keywords provided by Affective Neuroscience Laboratory:
Reward Processing
Wellbutrin
Bupropion

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014