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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Placebo
Sponsored by
Affective Neuroscience Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Reward Processing, Wellbutrin, Bupropion

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Depression Clinical and Research Program, Massachusetts General Hospital
  • Affective Neuroscience Laboratory, Department of Psychology, Harvard University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Bupropion

Arm Description

Outcomes

Primary Outcome Measures

Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
December 4, 2007
Sponsor
Affective Neuroscience Laboratory
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00205946
Brief Title
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
Official Title
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Affective Neuroscience Laboratory
Collaborators
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Reward Processing, Wellbutrin, Bupropion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Bupropion
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin XL
Intervention Description
150 mg of bupropion administered 5 hours before fMRI scanning
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)
Primary Outcome Measure Information:
Title
Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego A Pizzagalli, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Depression Clinical and Research Program, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Affective Neuroscience Laboratory, Department of Psychology, Harvard University
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

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

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