Trial Outcomes & Findings for Escitalopram in the Treatment of Dysthymic Disorder, Double Blind (NCT NCT00220701)

NCT ID: NCT00220701

Last Updated: 2015-11-11

Results Overview

Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\>50% decrease) Remission (score\<=7)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2015-11-11

Participant Flow

Participant milestones

Measure	Escitalopram Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Overall Study STARTED	17	17
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	Escitalopram Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Overall Study Lost to Follow-up	5	4

Baseline Characteristics

Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

Baseline characteristics by cohort

Measure	Escitalopram n=17 Participants Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=17 Participants inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Total n=34 Participants Total of all reporting groups
Age, Continuous	43.88 years STANDARD_DEVIATION 9.92 • n=5 Participants	43.59 years STANDARD_DEVIATION 11.33 • n=7 Participants	43.74 years STANDARD_DEVIATION 10.49 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)

Outcome measures

Measure	Escitalopram n=17 Participants Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=17 Participants inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Hamilton-Depression Rating Scale (HDRS-24 Items)	10.88 units on a scale Standard Deviation 5.83	16.41 units on a scale Standard Deviation 6.34

PRIMARY outcome

Timeframe: Baseline

Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)

Outcome measures

Measure	Escitalopram n=17 Participants Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=17 Participants inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Hamilton-Depression Rating Scale (HDRS-24 Items)	22.82 units on a scale Standard Deviation 5.75	24.41 units on a scale Standard Deviation 6.25

SECONDARY outcome

Timeframe: Week 12

Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)

Outcome measures

Measure	Escitalopram n=17 Participants Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=17 Participants inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Clinical Global Impressions - Severity (CGI-S)	2.35 units on a scale Standard Deviation 0.93	3.41 units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline

21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.

Outcome measures

Measure	Escitalopram n=17 Participants Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=17 Participants inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Beck Depression Inventory (BDI)	15.00 units on a scale Standard Deviation 5.21	16.25 units on a scale Standard Deviation 5.12

SECONDARY outcome

Timeframe: Baseline

Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)

Outcome measures

Measure	Escitalopram n=17 Participants Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=17 Participants inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Clinical Global Impressions - Severity (CGI-S)	4.06 units on a scale Standard Deviation 0.24	4.06 units on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: Week 12

21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.

Outcome measures

Measure	Escitalopram n=17 Participants Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=17 Participants inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Beck Depression Inventory (BDI)	6.76 units on a scale Standard Deviation 4.91	10.00 units on a scale Standard Deviation 5.16

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Escitalopram n=17 participants at risk Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)	Placebo n=15 participants at risk；n=17 participants at risk inactive comparator Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Gastrointestinal disorders Upset stomach	0.00% 0/17 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.	20.0% 3/15 • Number of events 3 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.
Reproductive system and breast disorders Decreased Libido	35.3% 6/17 • Number of events 6 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.	6.7% 1/15 • Number of events 1 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.
Reproductive system and breast disorders Delayed Ejection	17.6% 3/17 • Number of events 3 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.	0.00% 0/15 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.
Nervous system disorders Lightheadedness	17.6% 3/17 • Number of events 3 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.	0.00% 0/15 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.
General disorders Other	17.6% 3/17 • Number of events 3 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.	66.7% 10/15 • Number of events 10 • Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.

Additional Information

David Hellerstein MD

NY State Psychiatric Institute

Phone: 6467748000

Email: hellers@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place