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Trial record 3 of 482 for:    ESCITALOPRAM AND Antagonists

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

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ClinicalTrials.gov Identifier: NCT01876823
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mild Cognitive Impairment
Major Depressive Disorder
Alzheimer's Disease
Interventions Drug: es-citalopram
Drug: Memantine
Enrollment 60
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 Details 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
Hide 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
Reason Not Completed
Withdrawal by Subject             5
Physician Decision             2
Patients moved             2
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
35
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
65.3  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
22
  62.9%
Male
13
  37.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Hispanic or Latino
7
  20.0%
Not Hispanic or Latino
28
  80.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat.
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.5  (15)
2.Secondary Outcome
Title Change in Wechsler Memory Scale-III (WMS-III)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat.
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.9  (32.8)
3.Secondary Outcome
Title Change in Selective Reminding Test - Delayed Recall (SRT-DR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat.
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (3.9)
4.Secondary Outcome
Title Change in Trails B
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat.
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: seconds
-36.3  (74.5)
5.Secondary Outcome
Title Change in Trails A
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat.
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: seconds
1.9  (41.2)
6.Other Pre-specified Outcome
Title Change in 24-item HAMD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat.
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-15.2  (4.4)
7.Other Pre-specified Outcome
Title Change in Treatment Emergent Side Effects (TESS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat.
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
concurrent es-citalopram plus memantine were administered for 48 weeks.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
1
Time Frame From initiation of study until one month after study completion- a total of 13 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Es-citalopram and Memantine Treatment
Hide Arm/Group Description concurrent es-citalopram plus memantine were administered for 48 weeks.
All-Cause Mortality
Es-citalopram and Memantine Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Es-citalopram and Memantine Treatment
Affected / at Risk (%) # Events
Total   2/35 (5.71%)    
Cardiac disorders   
Syncopal Episode   1/35 (2.86%)  1
Nervous system disorders   
Dizziness   1/35 (2.86%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Es-citalopram and Memantine Treatment
Affected / at Risk (%) # Events
Total   4/35 (11.43%)    
Gastrointestinal disorders   
Nausea   1/35 (2.86%)  4
Nervous system disorders   
Headache   1/35 (2.86%)  4
Sedation   2/35 (5.71%)  4
Indicates events were collected by systematic assessment
  • 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
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
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01876823     History of Changes
Other Study ID Numbers: 6277R
First Submitted: June 5, 2013
First Posted: June 13, 2013
Results First Submitted: September 23, 2013
Results First Posted: October 24, 2014
Last Update Posted: October 24, 2014