Trial Outcomes & Findings for Investigation of Genetic Predictors of the Response to Selective Serotonin Re-uptake Inhibitors (SSRI) Treatment (NCT NCT03927950)

Results Overview

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".

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

135 participants

Primary outcome timeframe

the results are for a single time point (12 weeks)

Results posted on

2019-04-25

Participant Flow

Department of Psychiatry

Participant milestones

Participant milestones
Measure	Escitalopram Bupropion Open-label Escitalopram 10-20mg and Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
Overall Study STARTED	135
Overall Study COMPLETED	126
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Escitalopram Bupropion Open-label Escitalopram 10-20mg and Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
Overall Study Adverse Event	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=135 Participants Escitalopram 10-20mg; an open-label, placebo not controlled trial in a naturalistic setting
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	135 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	31 years STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	88 Participants n=99 Participants
Sex: Female, Male Male	47 Participants n=99 Participants
Region of Enrollment Estonia	135 participants n=99 Participants

PRIMARY outcome

Timeframe: the results are for a single time point (12 weeks)

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".

Outcome measures

Outcome measures
Measure	Escitalopram n=135 Participants Escitalopram 10-20mg; an open-label, placebo not controlled trial in a naturalistic setting
Montgomery-Asberg's Depression Rating Scale	9.2 score on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: The outcome was measured at the week 12

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".

Outcome measures

Outcome measures
Measure	Escitalopram n=135 Participants Escitalopram 10-20mg; an open-label, placebo not controlled trial in a naturalistic setting
Hamilton Rating Scale for Depression	7.2 score on a scale Standard Deviation 7.3

Adverse Events

Escitalopram Bupropion Open-label

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Escitalopram Bupropion Open-label n=135 participants at risk Escitalopram 10-20mg Bupropion 150-300mg; an open-label, placebo not controlled trial in a naturalistic setting
Gastrointestinal disorders nausea	3.7% 5/135 • During course of trial (12 weeks) 9 patients discontinued escitalopram treatment due to side effects (5 due to nausea, 4 due to sexual dysfunction)
Reproductive system and breast disorders sexual dysfunction	3.0% 4/135 • During course of trial (12 weeks) 9 patients discontinued escitalopram treatment due to side effects (5 due to nausea, 4 due to sexual dysfunction)

Additional Information

Eduard Maron

Department of Psychiatry, University of Tartu

Phone: +3727318812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place