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Trial record 44 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

Brain Effects of Escitalopram and Citalopram Using fMRI

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ClinicalTrials.gov Identifier: NCT00825825
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : September 3, 2012
Last Update Posted : July 14, 2015
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Michael Henry, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Antidepressant Activity in Healthy Volunteers
Interventions Drug: Escitalopram
Drug: Citalopram
Drug: Placebo
Enrollment 27
Recruitment Details Participants were recruited by advertisement from April 2008 until January 2011.
Pre-assignment Details Participants had their serotonin transporter genotyped. Individuals with a genotype of SS or SLg were not randomized. A total of 85 potential participants were screened. Of those, 21 were excluded on the basis of genotype. Another 28 were determined to be ineligible for other reasons and 6 withdrew prior to randomization.
Arm/Group Title Escitalopram First / Citalopram Second / Placebo Third Escitalopram First / Placebo Second / Citalopram Third Citalopram First / Escitalopram Second / Placebo Third Citalopram First / Placebo Second / Escitalopram Third Placebo First / Escitalopram Second / Citalopram Third Placebo First / Citalopram Second / Escitalopram Third
Hide Arm/Group Description 2 weeks of escitalopram followed by 2 weeks of citalopram followed by 2 weeks of placebo 2 weeks of escitalopram followed by 2 weeks of placebo followed by 2 weeks of citalopram 2 weeks of citalopram followed by 2 weeks of escitalopram followed by 2 weeks of placebo 2 weeks of citalopram followed by 2 weeks of placebo followed by 2 weeks of escitalopram 2 weeks of placebo followed by 2 weeks of escitalopram followed by 2 weeks of citalopram 2 weeks of placebo followed by 2 weeks of citalopram followed by 2 weeks escitalopram
Period Title: First Medication Period (14 Days)
Started 6 4 3 5 4 5
Completed 3 4 2 5 4 3
Not Completed 3 0 1 0 0 2
Reason Not Completed
Adverse Event             1             0             0             0             0             1
Physician Decision             2             0             1             0             0             1
Period Title: First Washout Period (14 Days)
Started 3 4 2 5 4 3
Completed 3 4 2 5 4 3
Not Completed 0 0 0 0 0 0
Period Title: Second Medication Period (14 Days)
Started 3 4 2 5 4 3
Completed 1 4 2 3 3 3
Not Completed 2 0 0 2 1 0
Reason Not Completed
Physician Decision             1             0             0             2             0             0
Protocol Violation             1             0             0             0             1             0
Period Title: Second Washout Period (14 Days)
Started 1 4 2 3 3 3
Completed 1 4 2 3 3 3
Not Completed 0 0 0 0 0 0
Period Title: Third Medication Period (14 Days)
Started 1 4 2 3 3 3
Completed 1 2 2 3 3 1
Not Completed 0 2 0 0 0 2
Reason Not Completed
Adverse Event             0             1             0             0             0             0
Protocol Violation             0             0             0             0             0             2
poor data quality             0             1             0             0             0             0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes all randomized subjects regardless of order in which they received medications
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
30.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
0
   0.0%
Male
27
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.
Hide Description Activation was measured using BOLD fMRI in response to happy and fearful faces presented in a rapid covert or masked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left middle temporal gyrus.
Time Frame two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.
Arm/Group Title All Participants With Complete Usable Data
Hide Arm/Group Description:
Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: voxels
478
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants With Complete Usable Data
Comments This analysis is a comparison between the escitalopram and citalopram medication periods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000704
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.
Hide Description Activation was measured using BOLD fMRI in response to affective faces and a fixation stimulus presented in an overt or unmasked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right insular cortex.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.
Arm/Group Title All Participants With Complete Usuable Data
Hide Arm/Group Description:
Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: voxels
735
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants With Complete Usuable Data
Comments This analysis is a comparison between the escitalopram and citalopram medication periods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000162
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
Hide Description Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right occipital fusiform gyrus.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.
Arm/Group Title All Participants With Complete Usable Data
Hide Arm/Group Description:
Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: voxels
658
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants With Complete Usable Data
Comments This analysis is a comparison between the citalopram and placebo medication periods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000936
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
Hide Description Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right lateral occipital cortex.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.
Arm/Group Title All Participants With Complete Usable Data
Hide Arm/Group Description:
Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: voxels
253
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants With Complete Usable Data
Comments This analysis is a comparison between the citalopram and placebo medication periods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
Hide Description Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right inferior lateral occipital cortex.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.
Arm/Group Title All Participants With Complete Usable Data
Hide Arm/Group Description:
Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: voxels
396
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants With Complete Usable Data
Comments This analysis is a comparison between the escitalopram and placebo medication periods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00124
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
Hide Description Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of placebo was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right lingual gyrus and right superior lateral occipital cortex.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.
Arm/Group Title All Participants With Complete Usable Data
Hide Arm/Group Description:
Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: voxels
619
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants With Complete Usable Data
Comments This analysis is a comparison between the placebo and citalopram medication periods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000633
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
Hide Description Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left primary visual cortex.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.
Arm/Group Title All Participants With Complete Usable Data
Hide Arm/Group Description:
Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: voxels
289
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants With Complete Usable Data
Comments This analysis is a comparison between the escitalopram and citalopram medication periods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0241
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Adverse event data was collected beginning with the date of the screening visit and ending with the final study visit. The average time period was approximately 4 months but varied due to differences in the length of the screening period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Citalopram Placebo
Hide Arm/Group Description Includes all subjects who received escitalopram in one of the three medication periods Includes all subjects who received citalopram in one of the three medication periods Includes all subjects who received placebo in one of the three medication periods
All-Cause Mortality
Escitalopram Citalopram Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/21 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Escitalopram Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      1/21 (4.76%)      1/21 (4.76%)    
General disorders       
nausea *  1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders       
headache *  1/22 (4.55%)  1 0/21 (0.00%)  0 1/21 (4.76%)  1
Psychiatric disorders       
insomnia *  0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Data from several subjects had to be excluded due to one or more fMRI scans with poor data quality (usually high motion) or scheduling problems that prevented a scan from occuring during the specified time window.
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: Tara Lauriat, Ph.D.
Organization: Steward St. Elizabeth's Medical Center
Phone: 617-789-2404
Responsible Party: Michael Henry, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT00825825     History of Changes
Other Study ID Numbers: 00397
First Submitted: January 19, 2009
First Posted: January 21, 2009
Results First Submitted: June 11, 2012
Results First Posted: September 3, 2012
Last Update Posted: July 14, 2015