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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205946
First Posted: September 21, 2005
Last Update Posted: December 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts General Hospital
Information provided by:
Affective Neuroscience Laboratory
  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 (Participant, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 6, 2007
Last Verified: November 2007

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
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors