The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity - Full Text View

Sponsor:	Affective Neuroscience Laboratory
Collaborator:	Massachusetts General Hospital
Information provided by:	Affective Neuroscience Laboratory
ClinicalTrials.gov Identifier:	NCT00205946

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 I

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:

MedlinePlus related topics: Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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

Additional Information:

Affective Neuroscience Laboratory, Department of Psychology, Harvard University This link exits the ClinicalTrials.gov site

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 February 13, 2012