The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
This study has been completed.
Sponsor:
Affective Neuroscience Laboratory
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
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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
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 May 21, 2013