Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2000-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Dementia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Sertraline

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age.

No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Not using any psychotropic medication which cannot be stopped 4 weeks before the study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No