Dopamine Receptor Imaging in Mood Disorders
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|ClinicalTrials.gov Identifier: NCT00116077|
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : July 2, 2017
This study seeks to increase the understanding of dopamine receptor function in the brain during major depressive disorder and bipolar depression, as well as genetic changes that may be behind changes in those receptors' actions. Dopamine is a natural messenger in the brain, involved in reward, motivation, and mood.
Volunteers aged 18 to 55 who have primary major depressive disorder and those who have bipolar depression (20 in each group), who are not HIV positive and do not have AIDS, and who are not pregnant or breastfeeding may be eligible for this study.
A telephone interview will be held, for patients to answer standardized questions about psychiatric or medical symptoms they may have experienced during their lifetime. Those eligible for the study will undergo interviews and laboratory tests. A psychiatric interview and clinical assessment will collect various data. Patients will undergo the following procedures and tests:
- A brief neurological examination
- A one-minute electrocardiogram to measure electrical activity of the heart.
- Laboratory tests measuring several substances in the blood and urine.
- Pregnancy test.
A magnetic resonance imaging (MRI) scan will be done to create an image of the volunteer's brain structure. The technique of MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the MRI scan, volunteers will lie still on a table that will slide into the scanner for 30 minutes and in some cases up to but no more than 90 minutes. Volunteers will be asked to lie as still as possible during the procedure. Then a PET system will create two images of brain blood flow-one of brain dopamine 1 receptor and one of dopamine 2/3 receptor binding. Volunteers will be given a radiotracer, a tiny amount of a drug that can be detected by a special camera in the PET scanner. A tiny flexible tube will be placed in the vein of one arm during each PET scan but during the MRI scan. Volunteers will be asked to lie still on the PET scanner table. A mask with large holes for eyes, ears, and mouth will be placed over the head, to keep the head from moving. After radiotracer injections are given, the PET scanner will create brain images. There may be two PET scanning sessions, each requiring about 3 hours of scanning. During only one of these there will be breaks. At the end of the scanning session, volunteers will be asked to drink several glasses of water and urinate immediately, to reduce radiation exposure to the bladder wall.
Genetic screening will help to enhance researchers' understanding of the role of dopamine receptors in depression. A small blood sample, about 2 tablespoons, will be collected, to isolate DNA from blood cells. Some of the blood samples or DNA may be stored for future studies, but those samples will remain coded, so participants will not be identified. This study will not have a direct benefit for participants. However, the results may provide knowledge to help people in the future. This study does involve compensation.
|Condition or disease|
|Mood Disorders Depressive Disorder, Major Bipolar Disorder|
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|Official Title:||Dopamine Receptor Imaging in Mood Disorders|
|Study Start Date :||June 21, 2005|
|Study Completion Date :||November 12, 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116077
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|