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Trial record 9 of 582 for:    ESCITALOPRAM

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01841125
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Seol-Heui Han, Konkuk University Medical Center

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.


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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


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841125


Locations
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Korea, Republic of
MedicalExcellence
Seoul, Secho-gu banpo-dong, Korea, Republic of, 505
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
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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

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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    Key Record Dates
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:
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Citalopram
Dexetimide
Depression
Alzheimer Disease
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