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

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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: escitalopram; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Secho-gu banpo-dong
    • Seoul, Secho-gu banpo-dong, Korea, Republic of, 505
      • MedicalExcellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: escitalopram; escitalopram 15mg	Drug: escitalopram; escitalopram 15mg, QD(once a day), Oral medication, 24weeks; Other Names: lexacure Tab
PLACEBO_COMPARATOR: Placebo; placebo 15mg	Drug: Placebo; placebo 15mg, QD(once a day), Oral medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.	Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.	24weeks
Change from baseline in K-MMSE at week 12 and 24.	Change from baseline in K-MMSE at week 12 and 24.	24 weeks
Change from baseline in ADAS-Cog at week 12 and 24.	Change from baseline in ADAS-Cog at week 12 and 24.	24 weeks
Change from baseline in NPIQ at week 12 and 24.	Change from baseline in NPIQ at week 12 and 24.	24 weeks
Change from baseline in S-IADL at week 12 and 24.	Change from baseline in S-IADL at week 12 and 24.	24 weeks
Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.	Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.	24 weeks
Change from baseline in CDR at week 12 and 24.	Change from baseline in CDR at week 12 and 24.	24 weeks
Change from baseline in CDR sum of box at week 12 and 24.	Change from baseline in CDR sum of box at week 12 and 24.	24 weeks
Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.	Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.	24 weeks

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Seol-Heui HAN, Professor, Kunkuk Universicy Hospital; Principal Investigator: Dong-Won YANG, Professor, Seoul St. Mary's Hospital; Principal Investigator: Sung-Yoon KIM, Professor, Asan Medical Center; Principal Investigator: Kun-Woo PARK, Professor, Korea University Hospital; Principal Investigator: Do-Hoon KIM, Professor, Hanlym University Hospital; Principal Investigator: So-Young MUN, Professor, Aju University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (ESTIMATE): April 26, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 12, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; depressive disorder
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: ADD_E_2010