Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of Genetic Predictors of the Response to Selective Serotonin Re-uptake Inhibitors (SSRI) Treatment

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: NCT03927950
Recruitment Status : Completed
First Posted : April 25, 2019
Results First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Eduard Maron, University of Tartu

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depression
Interventions Drug: escitalopram
Drug: bupropion
Enrollment 135
Recruitment Details Department of Psychiatry
Pre-assignment Details  
Arm/Group Title Escitalopram Bupropion Open-label
Hide Arm/Group Description Escitalopram 10-20mg and Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
Period Title: Overall Study
Started 135
Completed 126
Not Completed 9
Reason Not Completed
Adverse Event             9
Arm/Group Title Escitalopram
Hide Arm/Group Description Escitalopram 10-20mg; an open-label, placebo not controlled trial in a naturalistic setting
Overall Number of Baseline Participants 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
<=18 years
0
   0.0%
Between 18 and 65 years
135
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants
31  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
Female
88
  65.2%
Male
47
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Estonia Number Analyzed 135 participants
135
1.Primary Outcome
Title Montgomery-Asberg's Depression Rating Scale
Hide Description Ten-item diagnostic questionnaire to measure the severity of depressive symptoms. The lowest possible score on the scale is 0 and the highest possible score is 60. The lowest possible score on the scale represents “the lack of any depressive symptoms” and the highest score represents the “severe depressive symptoms”.
Time Frame the results are for a single time point (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Bupropion Open-label
Hide Arm/Group Description:
Escitalopram 10-20mg and Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
Overall Number of Participants Analyzed 135
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.2  (10.2)
2.Secondary Outcome
Title Hamilton Rating Scale for Depression
Hide Description 17-item diagnostic questionnaire to measure the severity of depressive symptoms. The lowest possible score on the scale is 0 and the highest possible score is 52. The lowest possible score on the scale represents “the lack of any depressive symptoms” and the highest score represents the “severe depressive symptoms”.
Time Frame The outcome was measured at the week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Escitalopram 10-20mg; an open-label, placebo not controlled trial in a naturalistic setting
Overall Number of Participants Analyzed 135
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.2  (7.3)
Time Frame During course of trial (12 weeks)
Adverse Event Reporting Description 9 patients discontinued escitalopram treatment due to side effects (5 due to nausea, 4 due to sexual dysfunction)
 
Arm/Group Title Escitalopram Bupropion Open-label
Hide Arm/Group Description Escitalopram 10-20mg Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
All-Cause Mortality
Escitalopram Bupropion Open-label
Affected / at Risk (%)
Total   0/135 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Bupropion Open-label
Affected / at Risk (%)
Total   0/135 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram Bupropion Open-label
Affected / at Risk (%)
Total   9/135 (6.67%) 
Gastrointestinal disorders   
nausea   5/135 (3.70%) 
Reproductive system and breast disorders   
sexual dysfunction   4/135 (2.96%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eduard Maron
Organization: Department of Psychiatry, University of Tartu
Phone: +3727318812
EMail: eduard.maron@kliinikum.ee
Layout table for additonal information
Responsible Party: Eduard Maron, University of Tartu
ClinicalTrials.gov Identifier: NCT03927950     History of Changes
Other Study ID Numbers: 2007-002649-19
7043 ( Other Grant/Funding Number: Ministry of Education, Estonia )
SF0180125s08 ( Other Grant/Funding Number: Ministry of Education, Estonia )
First Submitted: February 2, 2009
First Posted: April 25, 2019
Results First Submitted: February 2, 2009
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019