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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Bupropion

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • The Depression Clinical and Research Program, Massachusetts General Hospital
    • Cambridge, Massachusetts, United States, 02138
      • Affective Neuroscience Laboratory, Department of Psychology, Harvard University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Wellbutrin XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants.	1 day

Collaborators and Investigators

• Sponsor: Affective Neuroscience Laboratory
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Diego A Pizzagalli, PhD, Harvard University

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): December 6, 2007
• Last Update Submitted That Met QC Criteria: December 4, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Bupropion; Reward Processing; Wellbutrin
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 2004-P-002234-1; 2004-P002234-1