Major Depressive DisorderPhase 1NCT00205946
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
A Phase 1 study testing Bupropion in people with Major Depressive Disorder, run by Affective Neuroscience Laboratory at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL (bupropion hydrochloride) on reward processing. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2005to Jul 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114
Affective Neuroscience Laboratory, Department of Psychology, Harvard University
Cambridge, Massachusetts, 02138
About this study
The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL (bupropion hydrochloride) on reward processing.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Bupropion, Placebo
- Keywords
- Reward Processing, Wellbutrin, Bupropion
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Wellbutrin XL
150 mg of bupropion administered 5 hours before fMRI scanning
PlaceboDrug
Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Bupropion | Active comparator | Not described Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affective Neuroscience Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Investigators
- Diego A Pizzagalli, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205946
- Sponsor's protocol ID
- 2004-P-002234-1
- Other IDs
- 2004-P002234-1
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 6 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
- ClinicalTrials.gov ID
- NCT00205946
- Acronym / sponsor ID
- 2004-P-002234-1
- Conditions
- Major Depressive Disorder
- Keywords
- Reward Processing, Wellbutrin, Bupropion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Affective Neuroscience LaboratoryUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Apr 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Bupropion | Active comparator | Drug: Bupropion |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: Wellbutrin XL150 mg of bupropion administered 5 hours before fMRI scanning | Drug | Bupropion |
| PlaceboAdministered 5 hours prior to fMRI scanning (randomly assigned, double blind) | Drug | Placebo |
Primary outcome
Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego A Pizzagalli, PhD principal investigator
Harvard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupropion in people with Major Depressive Disorder, run by Affective Neuroscience Laboratory at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether an acute dose of bupropion vs. placebo differentially affects the neurobiology and behavior of reward processing in depressed participants. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2007; AzTrials last refreshed its copy on 8 Nov 2026.