Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)
|ClinicalTrials.gov Identifier: NCT00001777|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Drug: Sertraline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Official Title:||A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD)|
|Study Start Date :||December 1997|
|Study Completion Date :||May 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001777
|United States, Maryland|
|National Institute of Neurological Disorders and Stroke (NINDS)|
|Bethesda, Maryland, United States, 20892|