Bipolar Disorder Clinical Trial
Official title:
Dopamine Receptor Imaging in Mood Disorders
Verified date | November 12, 2010 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | November 12, 2010 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Abi-Dargham A, Mawlawi O, Lombardo I, Gil R, Martinez D, Huang Y, Hwang DR, Keilp J, Kochan L, Van Heertum R, Gorman JM, Laruelle M. Prefrontal dopamine D1 receptors and working memory in schizophrenia. J Neurosci. 2002 May 1;22(9):3708-19. — View Citation
Alheid GF, Heimer L. New perspectives in basal forebrain organization of special relevance for neuropsychiatric disorders: the striatopallidal, amygdaloid, and corticopetal components of substantia innominata. Neuroscience. 1988 Oct;27(1):1-39. Review. — View Citation
Allard P, Norlén M. Unchanged density of caudate nucleus dopamine uptake sites in depressed suicide victims. J Neural Transm (Vienna). 1997;104(11-12):1353-60. — View Citation
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