Brain Regulation of Emotions in People With Depression and Anhedonia (NCT00059579) | Clinical Trial Compass
CompletedNot Applicable
Brain Regulation of Emotions in People With Depression and Anhedonia
United States163 participantsStarted 2003-04-24
Plain-language summary
This study will use magnetic resonance imaging (MRI) to examine how the brain regulates emotions in healthy people and in patients who have major depression and anhedonia (loss of feeling of pleasure in things that normally give pleasure).
Healthy normal volunteers and patients between 18 and 50 years of age with major depression, with or without significant anhedonia, are eligible for this study. Candidates will be screened with a psychiatric interview, a physical examination that will include blood and urine samples, and an electrocardiogram, and a questionnaire about their emotions.
Participants will perform a monetary reward task while lying in an MRI scanner. The task is similar to playing a computer video game with the possibility of winning cash. The amount of cash is largely dependent on the subject's performance. The accumulated amount of cash earned in a session will fluctuate depending on the subject's continuing performance level. That is, during a single session, a subject could lose money earned early in the session if his or her performance later in the session is not as good as earlier.
MRI pictures will be taken during performance of the task. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that is moved into the scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure will last about 1 to 1-1/2 hours.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA
For both patient and control groups:
Age 18 to 50 of any ethnicity without other significant medical conditions
Not in active use of illicit drugs and heavy consumption of alcohol
No metallic implants or onplants that are ferromagnetic
Competent to sign consent forms to participate in the study.
For patient groups:
For the group with significant anhedonia, current MDD, as defined by DSM-IV criteria, with significant anhedonia defined as having PAS and/or SAS scores at or above one standard deviation of appropriate norm. For the group without significant anhedonia, current MDD, as defined by DSM-IV criteria, without significant anhedonia defined as having PAS and/or SAS scores within or below one standard deviation of appropriate norm. The BPD subjects will meet DSM-IV criteria for bipolar I or II disorder, most recent episode depressed and will currently be in a major depressive episode. We will use the Young Mania Rating Scale to assess the severity of the disorder Subjects may be enrolled as either inpatients or outpatients at their entrance to the study.
For control group:
No prior history of any psychiatric conditions including substance dependence
No family history of MDD, bipolar disorder, or psychosis
PAS and/or SAS scores within or below one standard deviation of appropriate norm.
EXCLUSION CRITERIA:
Medical conditions or concomitant medications that are likely to influence cerebral blood flow or neurological function including cardio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.