Escitalopram for the Treatment of Depression in Alzheimer's Disease
Information source: Konkuk University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: escitalopram (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Konkuk University Medical Center Official(s) and/or principal investigator(s):
Seol-Heui HAN, Professor, Principal Investigator, Affiliation: Kunkuk Universicy Hospital
Dong-Won YANG, Professor, Principal Investigator, Affiliation: Seoul St. Mary's Hospital
Sung-Yoon KIM, Professor, Principal Investigator, Affiliation: Asan Medical Center
Kun-Woo PARK, Professor, Principal Investigator, Affiliation: Korea University Hospital
Do-Hoon KIM, Professor, Principal Investigator, Affiliation: Hanlym University Hospital
So-Young MUN, Professor, Principal Investigator, Affiliation: AJU University Hospital
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups
Secondary outcome: 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.
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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
MedicalExcellence, Seoul, Secho-gu banpo-dong 505, Korea, Republic of
Additional Information
Starting date: November 2011
Last updated: August 12, 2014
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