Alzheimer's DiseasePhase 4EscitalopramNCT01841125
Escitalopram for the Treatment of Depression in Alzheimer's Disease
A Phase 4 study testing escitalopram in people with Alzheimer's Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- escitalopram, Placebo
- Keywords
- Alzheimer's Disease, depressive disorder
- Medical subject headings
- Alzheimer Disease, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called lexacure Tab
escitalopram 15mg, QD(once a day), Oral medication, 24weeks
PlaceboDrug
placebo 15mg, QD(once a day), Oral medication
| Study group | Role | What they receive |
|---|---|---|
| escitalopram | Experimental | escitalopram 15mg Receives: Drug: escitalopram |
| Placebo | Placebo comparator | placebo 15mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (9)
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.
Measured: 24weeks
Change from baseline in K-MMSE at week 12 and 24.
Change from baseline in K-MMSE at week 12 and 24.
Measured: 24 weeks
Change from baseline in ADAS-Cog at week 12 and 24.
Change from baseline in ADAS-Cog at week 12 and 24.
Measured: 24 weeks
Change from baseline in NPIQ at week 12 and 24.
Change from baseline in NPIQ at week 12 and 24.
Measured: 24 weeks
Change from baseline in S-IADL at week 12 and 24.
Change from baseline in S-IADL at week 12 and 24.
Measured: 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.
Measured: 24 weeks
Change from baseline in CDR at week 12 and 24.
Change from baseline in CDR at week 12 and 24.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seol-Heui Han, Konkuk University Medical Center
- Investigators
- Seol-Heui HAN, Professor, Principal investigator, Kunkuk Universicy HospitalDong-Won YANG, Professor, Principal investigator, Seoul St. Mary's HospitalSung-Yoon KIM, Professor, Principal investigator, Asan Medical CenterKun-Woo PARK, Professor, Principal investigator, Korea University HospitalDo-Hoon KIM, Professor, Principal investigator, Hanlym University HospitalSo-Young MUN, Professor, Principal investigator, AJU University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841125
- Sponsor's protocol ID
- ADD_E_2010
- Acronym
- Escitalopram
- Status last verified
- Aug 2014
- First submitted
- 18 Apr 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01841125
- Acronym / sponsor ID
- Escitalopram / ADD_E_2010
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, depressive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| escitalopram | Experimental | Drug: escitalopramescitalopram 15mg |
| Placebo | Placebo comparator | Drug: Placeboplacebo 15mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopramAlso: lexacure Tabescitalopram 15mg, QD(once a day), Oral medication, 24weeks | Drug | escitalopram |
| Placeboplacebo 15mg, QD(once a day), Oral medication | Drug | Placebo |
Primary outcome
Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups
Time frame: 12 weeks
Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups.
9 secondary outcomes
Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.
Time frame: 24weeks
Change from baseline in K-MMSE at week 12 and 24.
Time frame: 24 weeks
Change from baseline in ADAS-Cog at week 12 and 24.
Time frame: 24 weeks
Change from baseline in NPIQ at week 12 and 24.
Time frame: 24 weeks
Change from baseline in S-IADL at week 12 and 24.
Time frame: 24 weeks
Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.
Time frame: 24 weeks
Change from baseline in CDR at week 12 and 24.
Time frame: 24 weeks
Change from baseline in CDR sum of box at week 12 and 24.
Time frame: 24 weeks
Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seol-Heui HAN, Professor principal investigator
Kunkuk Universicy Hospital
Dong-Won YANG, Professor principal investigator
Seoul St. Mary's Hospital
Sung-Yoon KIM, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram in people with Alzheimer's Disease, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.