Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001478
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effects of Drugs on Cerebral Blood Flow in Patients With Mood Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Regional Cerebral Blood Flow Correlates of Spontaneous and Drug-Induced Clinical Changes in Mood Disorders
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 To determine differences in blood flow to the brain of patients with mood disorders compared to healthy volunteers
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
2 To determine changes in blood flow to the brain of patients with mood disorders who experience spontaneous changes in symptoms
3 To determine changes in blood flow to the brain of patients with mood disorders who receive various kinds of therapy medication transcranial magnetic stimulation etc
4 To determine if blood flow to specific areas of the brain can be used to predict how patients will respond to certain types of therapy
5 To compare blood flow changes with various other clinical and biochemical parameters
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 To determine differences in blood flow to the brain of patients with mood disorders compared to healthy volunteers
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
2 To determine changes in blood flow to the brain of patients with mood disorders who experience spontaneous changes in symptoms
3 To determine changes in blood flow to the brain of patients with mood disorders who receive various kinds of therapy medication transcranial magnetic stimulation etc
4 To determine if blood flow to specific areas of the brain can be used to predict how patients will respond to certain types of therapy
5 To compare blood flow changes with various other clinical and biochemical parameters
Detailed Description:
Patients with mood disorders and healthy volunteers will receive positron emission tomographic PET scans with H215O to measure global and local differences in cerebral blood flow during a passive introspection task Patients receive repeated scans while in different mood states and while participating in placebo controlled therapeutic trials as described by separate protocols Global and regional cerebral blood flow is correlated with data obtained from participation in other protocols which include clinical life charting course of illness parameters mood and anxiety ratings medication response data and psychological test performance and biochemical levels of medications monoamines and peptides in the blood and cerebrospinal fluid measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-M-0016 | None | None | None |