Dopamine Receptor Imaging in Mood Disorders

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00116077
First received: June 26, 2005
Last updated: November 13, 2010
Last verified: November 2010
  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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116077

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  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
Disease
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms
Pathologic Processes
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 September 22, 2014