CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
Sertralinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001777
NCT00001777Phase 1Completed

A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD)

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Dec 10, 2002·Updated Mar 4, 2008

In Brief

A Phase 1 clinical trial evaluating Sertraline for Dementia. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2002
Enrollment StartDec 1, 1997
Study CompletionMay 1, 2000
TodayJul 2, 2026
Posted 23.6 years ago

Interventions

Sertralinedrug