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

• ClinicalTrials.gov Identifier: NCT01841125
• Recruitment Status: Completed
• First Posted: April 26, 2013
• Last Update Posted: August 13, 2014
• Sponsor: Konkuk University Medical Center
• Information provided by (Responsible Party): Seol-Heui Han, Konkuk University Medical Center

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

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: escitalopram; Drug: Placebo	Phase 4

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: November 2011
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: escitalopram; escitalopram 15mg	Drug: escitalopram; escitalopram 15mg, QD(once a day), Oral medication, 24weeks; Other Name: lexacure Tab
Placebo Comparator: Placebo; placebo 15mg	Drug: Placebo; placebo 15mg, QD(once a day), Oral medication

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.
2. Change from baseline in K-MMSE at week 12 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in K-MMSE at week 12 and 24.
3. Change from baseline in ADAS-Cog at week 12 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in ADAS-Cog at week 12 and 24.
4. Change from baseline in NPIQ at week 12 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in NPIQ at week 12 and 24.
5. Change from baseline in S-IADL at week 12 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in S-IADL at week 12 and 24.
6. Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.
7. Change from baseline in CDR at week 12 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in CDR at week 12 and 24.
8. Change from baseline in CDR sum of box at week 12 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in CDR sum of box at week 12 and 24.
9. Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24. [ Time Frame: 24 weeks ]
   Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Korea, Republic of

MedicalExcellence

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

Sponsors and Collaborators

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

More Information

• Responsible Party: Seol-Heui Han, Clinical Professor, Konkuk University Medical Center
• ClinicalTrials.gov Identifier: NCT01841125 History of Changes
• Other Study ID Numbers: ADD_E_2010
• First Posted: April 26, 2013
• Last Update Posted: August 13, 2014
• Last Verified: August 2014

Keywords provided by Seol-Heui Han, Konkuk University Medical Center:

Alzheimer's Disease; depressive disorder

Additional relevant MeSH terms:

Dexetimide; Citalopram; Alzheimer Disease; Depression; Behavioral Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists