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Escitalopram for the Treatment of Depression in Alzheimer's Disease (Escitalopram)

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

escitalopram

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, depressive disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

MedicalExcellence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

escitalopram

Placebo

Arm Description

escitalopram 15mg

placebo 15mg

Outcomes

Primary Outcome Measures

Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups

Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups.

Secondary Outcome Measures

Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.

Change from baseline in K-MMSE at week 12 and 24.

Change from baseline in ADAS-Cog at week 12 and 24.

Change from baseline in NPIQ at week 12 and 24.

Change from baseline in S-IADL at week 12 and 24.

Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.

Change from baseline in CDR at week 12 and 24.

Change from baseline in CDR sum of box at week 12 and 24.

Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.

Full Information

NCT ID

NCT01841125

First Posted

April 18, 2013

Last Updated

August 12, 2014

Sponsor

Konkuk University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01841125

Brief Title

Escitalopram for the Treatment of Depression in Alzheimer's Disease

Acronym

Escitalopram

Official Title

A 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Konkuk University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Purpose : to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease Trial Design : A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial with an open-label, 12-week extension

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's Disease, depressive disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

escitalopram

Arm Type

Experimental

Arm Description

escitalopram 15mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo 15mg

Intervention Type

Drug

Intervention Name(s)

escitalopram

Other Intervention Name(s)

lexacure Tab

Intervention Description

escitalopram 15mg, QD(once a day), Oral medication, 24weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo 15mg, QD(once a day), Oral medication

Primary Outcome Measure Information:

Title

Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups

Description

Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.

Description

Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.

Time Frame

24weeks

Title

Change from baseline in K-MMSE at week 12 and 24.

Description

Change from baseline in K-MMSE at week 12 and 24.

Time Frame

24 weeks

Title

Change from baseline in ADAS-Cog at week 12 and 24.

Description

Change from baseline in ADAS-Cog at week 12 and 24.

Time Frame

24 weeks

Title

Change from baseline in NPIQ at week 12 and 24.

Description

Change from baseline in NPIQ at week 12 and 24.

Time Frame

24 weeks

Title

Change from baseline in S-IADL at week 12 and 24.

Description

Change from baseline in S-IADL at week 12 and 24.

Time Frame

24 weeks

Title

Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.

Description

Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.

Time Frame

24 weeks

Title

Change from baseline in CDR at week 12 and 24.

Description

Change from baseline in CDR at week 12 and 24.

Time Frame

24 weeks

Title

Change from baseline in CDR sum of box at week 12 and 24.

Description

Change from baseline in CDR sum of box at week 12 and 24.

Time Frame

24 weeks

Title

Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.

Description

Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: