Dopamine Receptor Imaging in Mood Disorders
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Purpose
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 |
|---|
|
Mood Disorders Depressive Disorder, Major Bipolar Disorder |
| Study Type: | Observational |
| Official Title: | Dopamine Receptor Imaging in Mood Disorders |
| Enrollment: | 145 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | November 2010 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
The presence of inclusion and exclusion criteria will be established using both unstructured psychiatric interview with a psychiatrist and the Structured Clinical Interview for DSM-IV (SCID; (Williams et al., 1992). Family history of mental illness will be obtained using the Family Interview of Genetic Studies (Maxwell, 1982).
MDD Depressed Sample: Forty-six subjects (ages 18-55) male and female will be selected, with primary MDD currently depressed as defined by DSM-IV criteria for recurrent MDD.
Bipolar Depressed Sample: Forty subjects (ages 18-55) male and female will be selected who meet DSM-IV criteria for bipolar I or II disorder and are currently depressed, with HDRS score in the moderately-to-severely depressed range (greater than 18). Subjects may be inpatients or outpatients. Because effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry.
Healthy, Control Sample: Forty-six subjects (ages 18-55) male and female who have not met criteria for any major psychiatric disorder will be selected. From this large sample a control subject will be matched to each depressed subject for age, gender, handedness and stage of menstrual cycle. The control subjects will have no known first degree relatives with mood disorders.
EXCLUSION CRITERIA:
Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular function for at least 3 weeks (8 weeks for fluoxetine and for any drug with known anticholinergic effects) prior to scanning. Because effective medications will not be discontinued for the purposes of this study, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry. Subjects will be excluded if they: a) have had serious suicidal ideation or behavior in the previous two months, or b) psychosis, or c) medical or neurological illnesses (i.e. seizure disorder, a coma in past) likely to affect physiology or anatomy, d) a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria), e) are HIV positive or have AIDS, f)current pregnancy (documented by history and pregnancy testing prior to scanning), g) current breast feeding, h) general MRI exclusion criteria which include the subject having a pacemaker or significant claustrophobia.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00116077 History of Changes |
| Other Study ID Numbers: | 050169, 05-M-0169 |
| Study First Received: | June 26, 2005 |
| Last Updated: | November 13, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
PET [C-11] NNC-112 [F-18] Fallypride Dopamine Receptors Mood Disorders DA Receptors |
Major Depressive Disorder Bipolar Disorder MDD Bipolar Depression Healthy Volunteer HV |
Additional relevant MeSH terms:
|
Bipolar Disorder Depressive Disorder Depression Mood Disorders Depressive Disorder, Major Affective Disorders, Psychotic Mental Disorders Behavioral Symptoms Dopamine Dopamine Agents Cardiotonic Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013