NCT00001478

Brief Summary

Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal biochemical and metabolic processes of the central nervous system of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive chemicals (H215O) and PET scans to observe what areas of the brain are receiving more blood flow. Patients diagnosed with mood disorders and healthy volunteers will receive positron emission tomographic (PET) scans with H215O while doing simple tasks. Patients will continue to receive scans while in different mood states and while taking different medications. Patients eligible for this study will be participating in other research studies measuring other clinical and biochemical parameters (mood and anxiety ratings, medication responses, and psychological test results). Information gathered from H215O PET scans measuring blood flow to specific brain areas will be compared to the data gathered from other studies. Objectives of this study are;

  1. 1.To determine differences in blood flow to the brain of patients with mood disorders compared to healthy volunteers.
  2. 2.To determine differences in blood flow to the brain of patients with subtype mood disorders (such as unipolar versus bipolar) compared to healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1994

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

HealthyMood Disorders

Keywords

BupropionCarbamazepineCerebral Blood FlowGabapentinLamotrigineMood DisordersNimodipineOxygen-15Positron Emission TomographyVenlafaxine

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Healthy volunteers and patients who satisfy DSM-III-R criteria for mood disorders between ages of 18 and 75 will be invited to participate provided that the following criteria are fulfilled: No history of medical illness (including seizures, endocrine, hepatic, renal, cardiac, allergic, infectious, autoimmune, or neurological disorders) that would contraindicate participation. No evidence of co-existing major illness after undergoing complete psychiatric (including SADS-LA interview), medical, neurological, and laboratory examinations (including EEG, EKG, renal and liver function tests, serum electrolytes, urinalysis, HIV, hepatitis B, syphilis). Negative pregnancy test for women of child bearing potential. Women must not be breast feeding. Negative HIV test, as we are studying primary mood and anxiety disorders and not disorders secondary to HIV infection. Negative urine comprehensive drug screen and have not had alcohol or substance abuse problems in last 12 months.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Cohen RM, Semple WE, Gross M, Nordahl TE, King AC, Pickar D, Post RM. Evidence for common alterations in cerebral glucose metabolism in major affective disorders and schizophrenia. Neuropsychopharmacology. 1989 Dec;2(4):241-54. doi: 10.1016/0893-133x(89)90028-6.

    PMID: 2610821BACKGROUND

  • Buchsbaum MS, DeLisi LE, Holcomb HH, Cappelletti J, King AC, Johnson J, Hazlett E, Dowling-Zimmerman S, Post RM, Morihisa J, et al. Anteroposterior gradients in cerebral glucose use in schizophrenia and affective disorders. Arch Gen Psychiatry. 1984 Dec;41(12):1159-66. doi: 10.1001/archpsyc.1984.01790230045007.

    PMID: 6334502BACKGROUND

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

October 1, 1994

Study Completion

January 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-01

Locations

US(1)