The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | December 4, 2007 | ||||
| Start Date ICMJE | April 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| 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 | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Major Depressive Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 32 | ||||
| Completion Date | July 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Concomitant medications other than those listed in the exclusion criteria will be considered on an individual basis. Oral contraceptives will be allowed. |
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00205946 | ||||
| Other Study ID Numbers ICMJE | 2004-P-002234-1, 2004-P002234-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Diego Pizzagalli, Principal Investigator, Harvard University | ||||
| Study Sponsor ICMJE | Affective Neuroscience Laboratory | ||||
| Collaborators ICMJE | Massachusetts General Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Affective Neuroscience Laboratory | ||||
| Verification Date | November 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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