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Trial record 83 of 585 for:    ESCITALOPRAM AND Celexa

Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression

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ClinicalTrials.gov Identifier: NCT01557946
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions MDD
Citalopram
Major Depressive Disorder
Intervention Drug: citalopram
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Citalopram 20 mg / 40 mg Healthy Control
Hide Arm/Group Description

Citalopram tablet taken once daily.

Only applicable to MDD participants. Every subject began on 20 mg, and had the option to titrate up to 40 mg.

No citalopram tablet taken.
Period Title: Overall Study
Started 20 12
Completed 17 [1] 12 [2]
Not Completed 3 0
Reason Not Completed
Adverse Event             3             0
[1]
20 consented and scanned - 1 subject's data not used due to ongoing neurological condition.
[2]
2 subjects with unusable imaging data.
Arm/Group Title Citalopram 20/40 mg Healthy Control Total
Hide Arm/Group Description Citalopram tablet taken once daily. No citalopram tablet taken. Total of all reporting groups
Overall Number of Baseline Participants 20 12 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 12 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
12
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 12 participants 32 participants
39.5  (12.7) 38.2  (14.1) 39.0  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 12 participants 32 participants
Female
9
  45.0%
7
  58.3%
16
  50.0%
Male
11
  55.0%
5
  41.7%
16
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 12 participants 32 participants
Hispanic or Latino
2
  10.0%
0
   0.0%
2
   6.3%
Not Hispanic or Latino
18
  90.0%
12
 100.0%
30
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 12 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.0%
1
   8.3%
2
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  15.0%
4
  33.3%
7
  21.9%
White
16
  80.0%
7
  58.3%
23
  71.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 12 participants 32 participants
20
 100.0%
12
 100.0%
32
 100.0%
1.Primary Outcome
Title Mean Difference From Baseline to Day 3 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group
Hide Description Estimated mean difference (day 3 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 3 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.
Time Frame Change from Baseline to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
One participant lacked a day 3 scan; one participant's day 3 scan was corrupted during data transfer and could not be recovered; and one participant's day 3 scan data was judged to be unusable due to poor spectral quality. Results are only presented for participants with depression as healthy control participants were only scanned once.
Arm/Group Title Participants With Depression
Hide Arm/Group Description:
Participants with depression receiving citalopram
Overall Number of Participants Analyzed 16
Mean (Standard Error)
Unit of Measure: arbitrary units
0.015  (0.032)
2.Secondary Outcome
Title Mean Difference From Baseline to Day 7 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group
Hide Description Estimated mean difference (day 7 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 7 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.
Time Frame Change from baseline to day 7
Hide Outcome Measure Data
Hide Analysis Population Description
One participant's day 7 scan was corrupted during data transfer and could not be recovered. Results are only presented for participants with depression as healthy control participants were only scanned once.
Arm/Group Title Participants With Depression
Hide Arm/Group Description:
Participants with depression receiving citalopram
Overall Number of Participants Analyzed 18
Mean (Standard Error)
Unit of Measure: arbitrary units
-0.0025  (0.031)
Time Frame Adverse events were collected during the duration of participant's participation in study (on average 8 weeks). Adverse events relate specifically to study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Citalopram 20 mg / 40 mg Healthy Control
Hide Arm/Group Description Citalopram tablet taken once daily. No citalopram tablet taken.
All-Cause Mortality
Citalopram 20 mg / 40 mg Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Citalopram 20 mg / 40 mg Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Citalopram 20 mg / 40 mg Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   19/19 (100.00%)   0/0 
Gastrointestinal disorders     
Abdominal Cramping   1/19 (5.26%)  0/0 
Constipation   1/19 (5.26%)  0/0 
Diarrhea   1/19 (5.26%)  0/0 
General disorders     
Headaches   9/19 (47.37%)  0/0 
Insomnia   6/19 (31.58%)  0/0 
Nausea   4/19 (21.05%)  0/0 
Sedation   4/19 (21.05%)  0/0 
Teeth Grinding   3/19 (15.79%)  0/0 
Vivid Dreams   2/19 (10.53%)  0/0 
Lethargy   3/19 (15.79%)  0/0 
Dry Mouth   2/19 (10.53%)  0/0 
Increased Sweating   2/19 (10.53%)  0/0 
Jaw clenching   1/19 (5.26%)  0/0 
Lightheadedness   1/19 (5.26%)  0/0 
"Heaviness in Eyelids"   1/19 (5.26%)  0/0 
"Spaciness"   1/19 (5.26%)  0/0 
Dizziness   1/19 (5.26%)  0/0 
Palpitations   1/19 (5.26%)  0/0 
Right-Sided Jaw Pain   1/19 (5.26%)  0/0 
Psychiatric disorders     
"Emotional Dulling"   1/19 (5.26%)  0/0 
Reproductive system and breast disorders     
Anorgasmia   2/19 (10.53%)  0/0 
Decreased Libido   1/19 (5.26%)  0/0 
Indicates events were collected by systematic assessment

Modest sample size due to participant attrition and the cost and logistical challenges of the study design.

Multiple comparisons, increasing the likelihood of type I errors. Open-label design which leaves open the possibility of a placebo effect.

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. Brian Brennan, MD
Organization: McLean Hospital, Biological Psychiatry Laboratory
Phone: 617-855-2911
Responsible Party: Brian P. Brennan, MD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01557946     History of Changes
Other Study ID Numbers: 2011-P-001192
First Submitted: March 9, 2012
First Posted: March 20, 2012
Results First Submitted: January 20, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017