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Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01876823
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
47
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause of disability and death in the elderly. Although a number of theoretical causes exist, the etiology of AD is still unknown. Consequently, the focus of treatments has been palliative, designed to ameliorate AD symptoms. Recent efforts, however, have revealed some surprising data suggesting that cholinesterase inhibitors (AchEIs), used over the last decade, and recently released memantine (an N-methyl-D-aspartate (NMDA) receptor antagonist), may confer protection to neurons. Thus, they may offer a slowing of cognitive decline and/or improvement in behavioral symptoms associated with memory impairment.

Over the last decade, it has been well documented that mild cognitive impairment (MCI) increases the risk of conversion to AD and that coincident depression and MCI (Dep-MCI) further increases the risk 2 to 3 fold. The primary focus of this line of investigation is to treat the very high risk to dement patient population with Dep-MCI, before they develop AD, in the hopes of delaying AD onset.

Memantine had not been studied in DEP-MCI patients. Since treatment of these patients with combined antidepressant and AChEIs has been associated with cognitive improvement in pilot studies, we explore whether treatment of DEP-MCI with memantine in addition to antidepressant treatment would benefit cognitive performance and lead to a low rate of conversion to dementia. We evaluate the cognitive and antidepressant benefit of combined open-label es-citalopram and memantine treatment over 48 weeks in a DEP-CI sample.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

The study is conducted in a sample of 35 elderly (50-90 years old) outpatients who meet study inclusion criteria for depression (DEP) (DSM-IV criteria for major depression, dysthymic disorder, or depression NOS) and mild cognitive impairment (MCI; e.g. operationally defined as between "normal" and "dementia"), i.e., Dep-MCI. The research plan includes: i) Obtaining a baseline psychiatric and neuropsychological test profile, ii) If currently on an ineffective antidepressant, having a one week washout (3 weeks for fluoxetine), iii) A treatment trial beginning with a two-week es-citalopram lead-in period. At two weeks, memantine (Namenda) is added starting at 5 mg/day and increased until the maximum dose of 20 mg/day is reached by six weeks. The study psychiatrist administers: the 24-item Hamilton Depression Rating Scale (HAM-D); the Clinical Global Impression (CGI, 1-7 scale) initial severity and subsequent change ratings separately for depression, cognition, and overall clinical status; the Treatment Emergent Symptom Scale (TESS) for somatic side effects. A trained technician administers the neuropsychological battery at baseline, 12, 24 and 48 weeks. If the patient is an antidepressant non-responder during the first 12-weeks, the es-citalopram is changed to an alternative antidepressant, as clinically indicated by the treating psychiatrist. The patient remains on the memantine for the entire 48-weeks, irrespective of antidepressant response.

This will tell us about the efficacy and tolerability of es-citalopram+memantine on both cognitive and depressive symptoms in Dep-MCI patients and will potentially have broader public health implications because Dep-MCI is a wide-spread clinical problem where management needs to be improved.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Combined Memantine (Namenda) Plus Escitalopram (Lexapro) Treatment in Elderly Depressed Patients With Cognitive Impairment
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: es-citalopram and Memantine Treatment

concurrent es-citalopram plus memantine were administered for 48 weeks.

Drug: es-citalopram
es-citalopram 10mg/day will be given for the first week, and 20mg/day starting at week 2.
Other Names:
  • Lexapro

    • Drug: Memantine
    After two weeks on Lexapro, Memantine 5mg will be added. The dose will increase to 10mg for the second week and will be increased at a rate of 5mg per week. Memantine dosage will not exceed 20mg.
    Other Names:
  • Namenda

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Selective Reminding Test - Total Immediate Recall (SRT-IR) [baseline, 48 weeks]

      Change in Selective Reminding Test-Total Immediate Recall (SRT-IR) scores from baseline to Week 48: Measures word recall (maximum 12 words per trial, across 6 trials). Maximum total recall score across 6 trials is 72; minimum recall is 0 across 6 trials. The higher the raw score, the better the patient did at recalling the target words. The unit of measure is the raw score, or the sum of the number of words recalled across all 6 trials.

    Secondary Outcome Measures

    1. Change in Wechsler Memory Scale-III (WMS-III) [Baseline, Week 48]

      Change in Wechsler Memory Scale-III scores from baseline to Week 48: The WMS-III Visual Reproduction sub-test was used to measure visual working memory and delayed memory. Patients were shown pictures of four drawings and were asked to reproduce them from memory immediately after seeing them, and 25 minutes after seeing them. The four scores are summed and the greater the total raw score, the better the patient did on the assessment. The maximum raw score for this test is a 41 on both the immediate and delayed portions (the overall range is 0-82 points). The change score is calculated using the total scores of both the immediate and delayed portions.

    2. Change in Selective Reminding Test - Delayed Recall (SRT-DR) [Baseline, Week 48]

      Change in Selective Reminding Test-Delayed Recall scores from baseline to Week 48: SRT Delay is administered 15 minutes after the immediate recall portion. Patients are asked to remember as many of the words as they can from the 6 trials. Maximum raw score is a 12 for free recall. If a patient is unable to recall a word, they are given a chance to recognize it among three incorrect word choices. Maximum raw score for recognition is 12. The greater the score on the delayed recall portion, the better the patient does on the assessment.

    3. Change in Trails B [Baseline, Week 48]

      Change from baseline to Week 48 on Trails B: Measures attention and executive function. It asks patients to connect numbers and letters in numerical to alphabetical order from (1-13 and A-L) as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers and letters, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.

    4. Change in Trails A [Baseline, Week 48]

      Change in Trails A scores from baseline to Week 48: Measures attention and executive function. It asks patients to connect numbers from 1-25 in numerical order as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.

    Other Outcome Measures

    1. Change in 24-item HAMD [Baseline, Week 48]

      Change in 24-item Hamilton Rating Scale for Depression (HAMD) scores from baseline to Week 48: HAMD measures depression severity based on a series of 24 items items. The range of HAMD total score is 0-74; 0 indicates no depressive symptoms and a maximum HAMD score is a 74, where the greater the score indicates more significant psychopathology. In this study, moderate to severe depression is considered a HAMD-24 greater than 14.

    2. Change in Treatment Emergent Side Effects (TESS) [Baseline, Week 48]

      Somatic side effect rating scale which includes 26 common somatic side effects associated with previous medication clinical trials; rated by the study physician. Factors were dichotomized to "yes" or "no" responses on this scale, which equated to the symptom being either present or not present. "Yes" and "no" responses were given a value of 0 (no) or 1 (yes). Responses from the entire group were calculated and the mean at baseline and the last visit is reported below.

    3. Change in Clinical Global Impression - Depression Change [Baseline, Week 48]

      The CGI Depression Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses were calculated for the entire group. Mean at final visit has been reported below. Higher mean at baseline indicates a decrease in depression scores.

    4. Change in Clinical Global Impression - Cognitive Change [Baseline, Week 48]

      The CGI Cognitive Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses from the entire group were calculated. Mean at final visit and baseline is reported below.

    5. Conversion to Dementia Using Clinical Dementia Rating (CDR) [Baseline, Week 48]

      The CDR is a numeric rating scale that is used to quantify the severity of one's cognitive function. The scale goes from 0=normal; 0.5=mild cognitive impairment; 1 to 3=mild to moderate/severe dementia. CDR was used a dichotomous outcome measure (no=0; yes=1).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Of either sex, age greater than 49 years old

    2. Meets criteria for both "depression" and "cognitive impairment".

    3. Study Criteria for "depression":

    1. Patients who meet DSM-IV criteria for Major Depression, Dysthymic Disorder, or Dysthymia symptoms criteria of minimum 6 month duration (not the 2 year DSM-IV criteria). ii. 24-item HAM-D greater than 13; and iii. Clinical Global Impression (CGI) for severity of Depression greater than 2 (absolute score at least mild to moderate depression on a 7-point scale)
    1. Study Criteria for "cognitive deficit":
    1. Subjective memory complaint ii.Mini Mental Status Exam (MMSE) greater than 24; and at least one of a, b, or c:

    1. less than 3 on MMSE 5 min delay on recall

    2. scores on 2 neuropsychological tests greater than 1 Standard Deviation (SD) below standardized norms, or

    3. score on 1 neuropsychological tests greater than 2 SD below standardized norms.

    Neuropsychological tests for inclusion criteria (subset of larger battery):

    Selective Reminding Test with delay Wechsler Memory Scale (WMS): Visual Reproduction - with delay, % savings from immed to delay Controlled Oral Word Association Test Trails B Digit symbol subtest of Wechsler Adult Intelligence Scale (WAIS)-III Continuous Performance Test iii. CGI for severity of Cognitive deficit greater than 2 (absolute score on a 7-point scale:1=no deficit to 7=severe deficit). iv. Clinical Dementia Rating (CDR) = 0 or 0.5

    1. Willing and capable of giving informed consent
    Exclusion Criteria:

    1. Meets Criteria for dementia (DSM-IV) or probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (NINCDS-ADRDA criteria)

    2. Meets criteria for:

    3. schizophrenia

    4. alcohol or substance dependence or abuse within the last 6 months.

    5. Suicidal attempt in last 6 months or current suicidal intent.

    6. Patients currently on an effective antidepressant medication

    7. Use of cholinesterase inhibitors in the last year.

    8. Neurological disease including stroke, epilepsy, or other neurodegenerative disorders.

    9. An acute, severe or unstable medical condition such as metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis.

    10. Patients who can not tolerate being tapered off antidepressant medication (i.e. greater than a 25% incr. in baseline HAM-D) or has a history indicating patient is unlikely to tolerate psychotropic washout.

    11. Patient with a history of non-response to Citalopram or es-citalopram

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York State Psychiatric Institute New York New York United States 10032

    Sponsors and Collaborators

    • New York State Psychiatric Institute

    Investigators

    • Principal Investigator: Gregory Pelton, M.D., New York State Psychiatric Institute
    • Study Chair: Davangere Devanand, M.D., New York State Psychiatric Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT01876823
    Other Study ID Numbers:
    • 6277R
    First Posted:
    Jun 13, 2013
    Last Update Posted:
    Oct 24, 2014
    Last Verified:
    Sep 1, 2013
    Keywords provided by New York State Psychiatric Institute
    Memory Decline
    Depression
    Elderly
    Antidepressants
    Treatment
    memantine
    Additional relevant MeSH terms:
    Alzheimer Disease
    Depressive Disorder
    Cognitive Dysfunction
    Depressive Disorder, Major
    Memantine
    Citalopram

    Study Results

    Participant Flow

    Recruitment Details 35 depressed and cognitively impaired patients were recruited from the Late Life Depression and Memory Disorders Clinic at Columbia University Medical Center.
    Pre-assignment Detail Any patients who were diagnosed with schizophrenia, psychoses, bipolar disorder, or alcohol/substance dependence (within the last 6 months) were excluded from participating in the study. Patients already on an effective anti-depressant, non-responders to citalopram/es-citalopram, and those on cholinesterase inhibitors/memantine were also excluded.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description This group received concurrent es-citalopram plus memantine treatment for 48 weeks. Patients ranged in age from 50-90 years old. Es-citalopram treatment began at 10mg per day for two weeks and was increased to 20mg per day for the 48 week duration. If a patient had an inadequate response to the antidepressant on two consecutive visits, the study physician used an alternative. At two weeks into the study, the patients were started on memantine 5mg, and the maximum dose of 20mg was reached by the six week point.
    Period Title: Overall Study
    STARTED 35
    COMPLETED 26
    NOT COMPLETED 9

    Baseline Characteristics

    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Overall Participants 35
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    0
    0%
    >=65 years
    35
    100%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.3
    (8.9)
    Sex: Female, Male (Count of Participants)
    Female
    22
    62.9%
    Male
    13
    37.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    7
    20%
    Not Hispanic or Latino
    28
    80%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    35
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)
    Description Change in Selective Reminding Test-Total Immediate Recall (SRT-IR) scores from baseline to Week 48: Measures word recall (maximum 12 words per trial, across 6 trials). Maximum total recall score across 6 trials is 72; minimum recall is 0 across 6 trials. The higher the raw score, the better the patient did at recalling the target words. The unit of measure is the raw score, or the sum of the number of words recalled across all 6 trials.
    Time Frame baseline, 48 weeks

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Mean (Standard Deviation) [units on a scale]
    7.5
    (15)
    2. Secondary Outcome
    Title Change in Wechsler Memory Scale-III (WMS-III)
    Description Change in Wechsler Memory Scale-III scores from baseline to Week 48: The WMS-III Visual Reproduction sub-test was used to measure visual working memory and delayed memory. Patients were shown pictures of four drawings and were asked to reproduce them from memory immediately after seeing them, and 25 minutes after seeing them. The four scores are summed and the greater the total raw score, the better the patient did on the assessment. The maximum raw score for this test is a 41 on both the immediate and delayed portions (the overall range is 0-82 points). The change score is calculated using the total scores of both the immediate and delayed portions.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Mean (Standard Deviation) [units on a scale]
    9.9
    (32.8)
    3. Secondary Outcome
    Title Change in Selective Reminding Test - Delayed Recall (SRT-DR)
    Description Change in Selective Reminding Test-Delayed Recall scores from baseline to Week 48: SRT Delay is administered 15 minutes after the immediate recall portion. Patients are asked to remember as many of the words as they can from the 6 trials. Maximum raw score is a 12 for free recall. If a patient is unable to recall a word, they are given a chance to recognize it among three incorrect word choices. Maximum raw score for recognition is 12. The greater the score on the delayed recall portion, the better the patient does on the assessment.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Mean (Standard Deviation) [units on a scale]
    1.2
    (3.9)
    4. Secondary Outcome
    Title Change in Trails B
    Description Change from baseline to Week 48 on Trails B: Measures attention and executive function. It asks patients to connect numbers and letters in numerical to alphabetical order from (1-13 and A-L) as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers and letters, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Mean (Standard Deviation) [seconds]
    -36.3
    (74.5)
    5. Secondary Outcome
    Title Change in Trails A
    Description Change in Trails A scores from baseline to Week 48: Measures attention and executive function. It asks patients to connect numbers from 1-25 in numerical order as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Mean (Standard Deviation) [seconds]
    1.9
    (41.2)
    6. Other Pre-specified Outcome
    Title Change in 24-item HAMD
    Description Change in 24-item Hamilton Rating Scale for Depression (HAMD) scores from baseline to Week 48: HAMD measures depression severity based on a series of 24 items items. The range of HAMD total score is 0-74; 0 indicates no depressive symptoms and a maximum HAMD score is a 74, where the greater the score indicates more significant psychopathology. In this study, moderate to severe depression is considered a HAMD-24 greater than 14.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Mean (Standard Deviation) [scores on a scale]
    -15.2
    (4.4)
    7. Other Pre-specified Outcome
    Title Change in Treatment Emergent Side Effects (TESS)
    Description Somatic side effect rating scale which includes 26 common somatic side effects associated with previous medication clinical trials; rated by the study physician. Factors were dichotomized to "yes" or "no" responses on this scale, which equated to the symptom being either present or not present. "Yes" and "no" responses were given a value of 0 (no) or 1 (yes). Responses from the entire group were calculated and the mean at baseline and the last visit is reported below.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat.
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Treatment Emergent Side Effects (Baseline)
    6.6
    (4.2)
    Treatment Emergent Side Effects (WK 48)
    3.2
    (2.9)
    8. Other Pre-specified Outcome
    Title Change in Clinical Global Impression - Depression Change
    Description The CGI Depression Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses were calculated for the entire group. Mean at final visit has been reported below. Higher mean at baseline indicates a decrease in depression scores.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Cognitive Global Impression at Baseline
    4.1
    (0.5)
    Cognitive Global Impression at Final Visit (WK 48)
    2.1
    (1.2)
    9. Other Pre-specified Outcome
    Title Change in Clinical Global Impression - Cognitive Change
    Description The CGI Cognitive Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses from the entire group were calculated. Mean at final visit and baseline is reported below.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    CGI-Cognitive Change (Baseline)
    3.6
    (0.6)
    Clinical Global Impression-Cogntive Change (WK 48)
    2.7
    (0.9)
    10. Other Pre-specified Outcome
    Title Conversion to Dementia Using Clinical Dementia Rating (CDR)
    Description The CDR is a numeric rating scale that is used to quantify the severity of one's cognitive function. The scale goes from 0=normal; 0.5=mild cognitive impairment; 1 to 3=mild to moderate/severe dementia. CDR was used a dichotomous outcome measure (no=0; yes=1).
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    Measure Participants 35
    Number [participants]
    1
    2.9%

    Adverse Events

    Time Frame From initiation of study until one month after study completion- a total of 13 months.
    Adverse Event Reporting Description
    Arm/Group Title Es-citalopram and Memantine Treatment
    Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
    All Cause Mortality
    Es-citalopram and Memantine Treatment
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Es-citalopram and Memantine Treatment
    Affected / at Risk (%) # Events
    Total 2/35 (5.7%)
    Cardiac disorders
    Syncopal Episode 1/35 (2.9%) 1
    Nervous system disorders
    Dizziness 1/35 (2.9%) 1
    Other (Not Including Serious) Adverse Events
    Es-citalopram and Memantine Treatment
    Affected / at Risk (%) # Events
    Total 4/35 (11.4%)
    Gastrointestinal disorders
    Nausea 1/35 (2.9%) 4
    Nervous system disorders
    Headache 1/35 (2.9%) 4
    Sedation 2/35 (5.7%) 4

    Limitations/Caveats

    The inclusion criteria required all patients to have an MMSE of 24 or higher, which may have lowered the conversion rate to dementia small sample size cognitive improvement may have been due in part to combined es-citalopram and memantine

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Gregory Pelton, MD
    Organization Columbia Psychiatry
    Phone (646) 774-8669
    Email ghp4@columbia.edu
    Responsible Party:
    New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT01876823
    Other Study ID Numbers:
    • 6277R
    First Posted:
    Jun 13, 2013
    Last Update Posted:
    Oct 24, 2014
    Last Verified:
    Sep 1, 2013