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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 4, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Objective Behavioral Measure of Reward Processing

Change History

Complete list of historical versions of study NCT00205946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: Bupropion
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00205946

Responsible Party

Diego Pizzagalli, Principal Investigator, Harvard University

Study ID Numbers ^ICMJE

2004-P-002234-1, 2004-P002234-1

Study Sponsor ^ICMJE

Affective Neuroscience Laboratory

Collaborators ^ICMJE

Massachusetts General Hospital

Investigators ^ICMJE

Principal Investigator:

Diego A Pizzagalli, PhD

Harvard University

Information Provided By

Affective Neuroscience Laboratory

Verification Date

November 2007

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