Trial Outcomes & Findings for Desvenlafaxine vs. Placebo Treatment of Chronic Depression (NCT NCT01537068)

NCT ID: NCT01537068

Last Updated: 2017-09-11

Results Overview

HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 59 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-09-11

Participant Flow

Participant milestones

Measure	Desvenlafaxine Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo Placebo treatment Placebo: Matching placebo pills
Overall Study STARTED	30	29
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Desvenlafaxine Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo Placebo treatment Placebo: Matching placebo pills
Overall Study Lost to Follow-up	2	1
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	1
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

Desvenlafaxine vs. Placebo Treatment of Chronic Depression

Baseline characteristics by cohort

Measure	Desvenlafaxine n=30 Participants SNRI antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo n=29 Participants Placebo treatment Placebo: Matching placebo pills	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.80 years STANDARD_DEVIATION 14.18 • n=5 Participants	36.28 years STANDARD_DEVIATION 11.65 • n=7 Participants	38.07 years STANDARD_DEVIATION 13.01 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	29 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression

Outcome measures

Measure	Desvenlafaxine n=30 Participants SNRI antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo n=29 Participants Placebo treatment Placebo: Matching placebo pills
Hamilton Rating Scale for Depression (HDRS24)	14.63 units on a scale Standard Deviation 3.39	14.21 units on a scale Standard Deviation 3.50

PRIMARY outcome

Timeframe: Week 12

HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression

Outcome measures

Measure	Desvenlafaxine n=30 Participants SNRI antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo n=29 Participants Placebo treatment Placebo: Matching placebo pills
Hamilton Rating Scale for Depression (HDRS24)	6.53 units on a scale Standard Deviation 3.98	8.24 units on a scale Standard Deviation 4.86

SECONDARY outcome

Timeframe: 12 weeks

Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.

Outcome measures

Measure	Desvenlafaxine n=26 Participants SNRI antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo n=26 Participants Placebo treatment Placebo: Matching placebo pills
Response Rate	16 Participants	7 Participants

Adverse Events

Desvenlafaxine

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Desvenlafaxine n=30 participants at risk SNRI antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo n=29 participants at risk Placebo treatment Placebo: Matching placebo pills
Nervous system disorders Seizure	0.00% 0/30	3.4% 1/29 • Number of events 1

Other adverse events

Measure	Desvenlafaxine n=30 participants at risk SNRI antidepressant drug Desvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day	Placebo n=29 participants at risk Placebo treatment Placebo: Matching placebo pills
Metabolism and nutrition disorders Decreased sleep	33.3% 10/30 • Number of events 10	13.8% 4/29 • Number of events 4
Metabolism and nutrition disorders Daytime Sleepiness	30.0% 9/30 • Number of events 9	17.2% 5/29 • Number of events 5
General disorders Headache	30.0% 9/30 • Number of events 9	13.8% 4/29 • Number of events 4
General disorders Nausea	30.0% 9/30 • Number of events 9	10.3% 3/29 • Number of events 3
Gastrointestinal disorders Dry Mouth	23.3% 7/30 • Number of events 7	6.9% 2/29 • Number of events 2
General disorders Agitation	16.7% 5/30 • Number of events 5	0.00% 0/29
General disorders Dizziness	16.7% 5/30 • Number of events 5	0.00% 0/29
General disorders Sweating	16.7% 5/30 • Number of events 5	6.9% 2/29 • Number of events 2

Additional Information

David Hellerstein MD

NYSPI

Phone: 646-774-8000

Email: desdesk@nyspi.columbia.edu

Results disclosure agreements

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