Completed

EscitalopramA 12-Week Randomized, Double-blind, Parallel-group, Placebo-controlled Trial With and Open-label, 12-week Extension, Multicenter to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease

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What is being tested

escitalopram

+ Placebo

Drug
Who is being recruted

Mental Disorders+8

+ Brain Diseases

+ Central Nervous System Diseases

Over 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: November 2011
See protocol details

Summary

Principal SponsorKonkuk University Medical Center
Last updated: August 13, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2011

Actual date on which the first participant was enrolled.

Clinical trial agreement signed by the parties to the subjects through a process of screening. if it is consider suitable for evaluating through the selection / exclusion criteria, they will be randomly assigned to the test group or control group (placebo). Assigned to the test group or control subjects, they will be prescribe the 5mg Escitalopram or Placebo. without regard to meals, it will be taking once a day. and than It should be increased the capacity every two weeks by 5mg/day up to a maximum 15mg/day. and than, on the treatment for a 8 weeks, If you don't find the side effect, Maintaining the same capacity. If you find the side effect, you should lose capacity.(10mg/day) The test group or control subjects, will receive a doctor's examination and inspection through six visits for a 24weeks from the date of the randomly assigned participants.

Principal SponsorKonkuk University Medical Center
Last updated: August 13, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesMood DisordersNeurocognitive DisordersTauopathiesAlzheimer DiseaseDepressive Disorder

Criteria

Inclusion Criteria: 1) over the age of 50 2) Medical diagnostic criteria must meet the standard. Subject diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA Criteria. Subject with three or more symptoms of the Olin depression (major depressive episode) diagnostic criteria. clinical dementia rating (CDR) of 0.5 to 2 MMSE 10 ~ 26 (K-MMSE) GDS-15 ≥ 5 points 3) When screening, Cholinesterase inhibitors taking a minimum of four weeks or more stable subject. 4) During the clinical trials, Subject does not change the capacity of Cholinesterase Inhibitors. 5) MRI or CT results within 24 months of subject with Alzheimer's disease (AD) 6) Participation in clinical trials to determine their own and written informed consent form and subject who actively perform clinical procedure including the questionnaire. But the subjects with cognitive dysfunction that cannot voluntarily make the decision, can be determined by an authorized representative to participate in. 7) Subjects must be accompanied their guardian to every visit. More than three days a week, more than 4 hours per day, spend the day with the guardian. Exclusion Criteria: If you are taking other depression drugs within 4 weeks before the start of the clinical trials(e.g. SSRI, Stablon, TCA, wellbutrin, ixel) If you have any other mental illness (bipolar disorder, schizophrenia, etc.) If you have a serious medical illness (heart failure, angina pectoris, myocardial infarction, arteriosclerosis, etc.) or psychiatric illness. Seizures, brain surgery, organic brain disease and history of organic affective disorder and at the brain MRI, abnormalities other than brain atrophy. If you have a history of the test drug hypersensitivity If you are taking memantin (dementia) If you participated in another clinical trial within 3 months. If pregnant or fertile women, who have not received sterilization or if you do not want to use an effective method of contraception. In laboratory tests, if you have kidney failure or liver failure. If you have history or habitual drinking or a history of drug abuse. Uncontrolled diabetes or hypertension. If determined to be inappropriate for clinical trials.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
escitalopram 15mg

Group II

Placebo
placebo 15mg

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

MedicalExcellence

Seoul, South KoreaOpen MedicalExcellence in Google Maps
CompletedOne Study Center