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

NCT00205946 | Completed Phase 1 DMC

• 2 other identifiers: 2004-P-002234-12004-P002234-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Reward Processing; Wellbutrin; Bupropion

Outcome Measures

Primary Outcomes (1)

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

  1 day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Bupropion

ACTIVE COMPARATOR

Drug: Bupropion

Interventions

Bupropion DRUG

150 mg of bupropion administered 5 hours before fMRI scanning

Also known as: Wellbutrin XL

Bupropion

Placebo DRUG

Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affective Neuroscience Laboratory: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

The Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Affective Neuroscience Laboratory, Department of Psychology, Harvard University

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Diego A Pizzagalli, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2005
• Study Completion: July 1, 2007
• Last Updated: December 6, 2007

Record last verified: 2007-11

Locations

US (2)