Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001777
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Sertraline for the Treatment of Patients With Frontal Lobe Dementia FLD
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Controlled Randomized Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia FLD
Status:
COMPLETED
Status Verified Date:
1998-11
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:
Dementia refers to a condition where there is a loss of intellectual function cognition It is usually a progressive condition that interferes with normal social and occupational activities
Patients with frontal lobe dementia FLD suffer from a destruction of the brain cells found in the frontal lobe of the brain Loss of frontal lobe neurons can cause changes in personality such as aggressiveness agitation and depression In addition patients with FLD may have difficulty planning tasks and may have a loss of motivation
Researchers believe that the cells lost in the frontal lobe of the brain are responsible for producing a chemical called serotonin Serotonin is a neurotransmitter which means it is used by neurons to communicate with other neurons Researchers are inclined to believe that by replacing the missing serotonin symptoms of FLD may be relieved
Drugs known as serotonin uptake inhibitors help to maintain high levels of serotonin in the body They have been used successfully to treat patients with depression and patients with violent impulsive behaviors Sertraline is a serotonin reuptake blocker that is relatively easy to give once daily is safer than most other serotonin reuptake blockers very little effect on vital enzyme systems cytochrome P-450 and has few interactions with other drugs
This study is designed to test the effectiveness of Sertraline for the treatment of symptoms associated with FLD Patients participating in the study will receive Sertraline for 6 weeks and a placebo inactive sugar pill for 6 weeks During the study researchers will test psychological and neurological functions to measure the effects of the drug
Patients with frontal lobe dementia FLD suffer from a destruction of the brain cells found in the frontal lobe of the brain Loss of frontal lobe neurons can cause changes in personality such as aggressiveness agitation and depression In addition patients with FLD may have difficulty planning tasks and may have a loss of motivation
Researchers believe that the cells lost in the frontal lobe of the brain are responsible for producing a chemical called serotonin Serotonin is a neurotransmitter which means it is used by neurons to communicate with other neurons Researchers are inclined to believe that by replacing the missing serotonin symptoms of FLD may be relieved
Drugs known as serotonin uptake inhibitors help to maintain high levels of serotonin in the body They have been used successfully to treat patients with depression and patients with violent impulsive behaviors Sertraline is a serotonin reuptake blocker that is relatively easy to give once daily is safer than most other serotonin reuptake blockers very little effect on vital enzyme systems cytochrome P-450 and has few interactions with other drugs
This study is designed to test the effectiveness of Sertraline for the treatment of symptoms associated with FLD Patients participating in the study will receive Sertraline for 6 weeks and a placebo inactive sugar pill for 6 weeks During the study researchers will test psychological and neurological functions to measure the effects of the drug
Detailed Description:
Degeneration of frontal serotonin-containing neurons occurs in frontal lobe dementia FLD The associated loss of serotonin transmission may contribute to the frontal lobe dysfunction associated with this disorder FLD patients will undergo a controlled clinical trial of an orally administered serotonergic agent Sertraline which acts centrally to selectively block serotonin uptake to treat patients cognitive and behavioral frontal dysfunction Study subjects will be evaluated at regular intervals with a battery of neuropsychological and behavioral tests designed to assess frontal and other cognitive functions In addition compliance and levels of the medication will be measured in the blood and when possible in the cerebrospinal fluid CSF
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 |
|---|---|---|---|
| 98-N-0046 | None | None | None |