Trial Outcomes & Findings for Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression (NCT NCT02235064)

NCT ID: NCT02235064

Last Updated: 2018-03-29

Results Overview

Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment 0 = No postpartum depression up to 12 weeks following discharge from hospital 1 = Postpartum depression up to 12 weeks following discharge from hospital

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: Discharge from hospital to 12 weeks postpartum
• Results posted on: 2018-03-29

Participant Flow

Participant milestones

Measure	Sertraline Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression

Baseline characteristics by cohort

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm	Total n=2 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	33 years n=5 Participants	30 years n=7 Participants	31.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Discharge from hospital to 12 weeks postpartum

Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment

0 = No postpartum depression up to 12 weeks following discharge from hospital

1 = Postpartum depression up to 12 weeks following discharge from hospital

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Discharge from hospital to 12 weeks postpartum

The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Reported Infant Weight at 4 Weeks Following Delivery	3033 Grams Interval 3033.0 to 3033.0	2750 Grams Interval 2750.0 to 2750.0

SECONDARY outcome

Timeframe: 4 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Reported Infant Weight at 8 Weeks Following Delivery	5301 Grams Interval 5301.0 to 5301.0	3685 Grams Interval 3685.0 to 3685.0

SECONDARY outcome

Timeframe: 12 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Reported Infant Weight at 12 Weeks Following Delivery	5301 Grams Interval 5301.0 to 5301.0	4734 Grams Interval 4734.0 to 4734.0

SECONDARY outcome

Timeframe: 8 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks postpartum

Outcome measures

Measure	Sertraline n=1 Participants Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 Participants Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum	0 Participants	0 Participants

Adverse Events

Sertraline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sertraline n=1 participants at risk Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper	Placebo n=1 participants at risk Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm
Gastrointestinal disorders Constipation	0.00% 0/1 • 12 weeks	100.0% 1/1 • Number of events 1 • 12 weeks

Additional Information

Dr. Richard L Fischer

Cooper University Health System

Phone: 856-342-2491

Email: fischer-richard@cooperhealth.edu

Results disclosure agreements

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