Escitalopram for the Treatment of Depression in Alzheimer's Disease

NCT ID: NCT01841125

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-07-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

escitalopram

escitalopram 15mg

Group Type: EXPERIMENTAL

escitalopram

Intervention Type: DRUG

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

Placebo

placebo 15mg

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

escitalopram

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

lexacure Tab

Eligibility Criteria

Inclusion Criteria

1) over the age of 50

2) Medical diagnostic criteria must meet the standard.

1. Subject diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA Criteria.

2. Subject with three or more symptoms of the Olin depression (major depressive episode) diagnostic criteria.

3. clinical dementia rating (CDR) of 0.5 to 2

4. MMSE 10 ~ 26 (K-MMSE)

5. 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

1. If you are taking other depression drugs within 4 weeks before the start of the clinical trials(e.g. SSRI, Stablon, TCA, wellbutrin, ixel)

2. If you have any other mental illness (bipolar disorder, schizophrenia, etc.)

3. If you have a serious medical illness (heart failure, angina pectoris, myocardial infarction, arteriosclerosis, etc.) or psychiatric illness.

4. Seizures, brain surgery, organic brain disease and history of organic affective disorder and at the brain MRI, abnormalities other than brain atrophy.

5. If you have a history of the test drug hypersensitivity

6. If you are taking memantin (dementia)

7. If you participated in another clinical trial within 3 months.

8. If pregnant or fertile women, who have not received sterilization or if you do not want to use an effective method of contraception.

9. In laboratory tests, if you have kidney failure or liver failure.

10. If you have history or habitual drinking or a history of drug abuse.

11. Uncontrolled diabetes or hypertension.

12. If determined to be inappropriate for clinical trials.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seol-Heui Han

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seol-Heui HAN, Professor

Role: PRINCIPAL_INVESTIGATOR

Kunkuk Universicy Hospital

Dong-Won YANG, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Sung-Yoon KIM, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Kun-Woo PARK, Professor

Role: PRINCIPAL_INVESTIGATOR

Korea University Hospital

Do-Hoon KIM, Professor

Role: PRINCIPAL_INVESTIGATOR

Hanlym University Hospital

So-Young MUN, Professor

Role: PRINCIPAL_INVESTIGATOR

AJU University Hospital

Locations

MedicalExcellence

Seoul, Secho-gu Banpo-dong, South Korea

Countries

South Korea

Other Identifiers

ADD_E_2010

Identifier Type: -

Identifier Source: org_study_id