Depression Clinical Trial
Official title:
Neuroimaging Studies of Reward Processing in Depression
Verified date | April 2014 |
Source | Mclean Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
This study will examine brain responses associated with reinforcement and reward tasks in individuals with major depressive disorder (MDD).
Status | Completed |
Enrollment | 87 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Overall Inclusion Criteria: - Right-handed - Agrees to use an effective form of contraception throughout the study Inclusion Criteria for Depressed Participants: - Meets overall inclusion criteria - Meets DSM-IV diagnosis criteria for major depressive disorder - Score of at least 16 on the 21-item HAM-D scale Overall Exclusion Criteria: - Left-handed or ambidextrous - Claustrophobic - Neurological or medical illness (e.g., attention deficit hyperactivity disorder, head injury, loss of consciousness, seizures) - Pregnant Exclusion Criteria for Depressed Participants: - Meets any of the overall exclusion criteria - Has been treated with electroconvulsive therapy within 6 months of study entry - Has taken any benzodiazepine medications for at least 2 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study - Has taken any dopaminergic medications (including methylphenidate) or neuroleptics for at least 6 months prior to study entry and discontinued use of the medication for reasons other than participating in the study - Has taken any fluoxetine medications for at least 6 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study - Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry - Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry - Current or past history of MDD with psychotic features - Meets DSM-IV diagnosis criteria for organic mental disorder; substance use disorder (within 1 year of study entry); lifetime substance dependence; schizophrenia; delusional disorder; bipolar disorder; post-traumatic stress disorder; eating disorder; acute bereavement; severe borderline or antisocial personality disorder; or any psychotic disorder not otherwise specified - Current primary diagnosis of panic disorder, social phobia, generalized anxiety disorder, obsessive-compulsive disorder, or somatoform disorder Exclusion Criteria for Control Participants - Meets any of the overall exclusion criteria - Diagnosed with any medical or neurological illness - Diagnosed with any current or past psychiatric illness, as assessed by the SCID-I, including substance abuse or dependence (e.g., alcohol) - Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry - Has taken any psychotropic medications within 2 weeks of study entry - Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry Exclusion Criteria for fMRI Studies: - Meets any of the overall exclusion criteria - Fails to meet safety standards for fMRI - Current back problems - Has strongly corrected vision, but does not wear contact lenses - Weighs more than 250 pounds or exceeds the limit of height-to-weight ratio for a comfortable fit in the scanner - Pregnant - Current alcohol or substance abuse - At risk for suicide or homicide |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | The Depression Clinical and Research Program, Massachusetts General Hospital | Boston | Massachusetts |
United States | Affective Neuroscience Laboratory, Department of Psychology, Harvard University | Cambridge | Massachusetts |
United States | Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital | Charlestown | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance on Monetary Incentive Delay task | This task features balanced incentive delivery and analytic strategies designed to identify activity specific to anticipation or consumption of incentives. | Given once during the second session for half an hour, and once during the third session for half an hour | No |
Primary | Signal detection reward task | This reward task provides an objective assessment of hedonic capacity. Due to the probabilistic nature of the task, participants cannot infer which stimulus is more advantageous based on the outcome of single trials but need to integrate reinforcement history over time to optimize behavior. | Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes | No |
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