Trial Outcomes & Findings for Escitalopram (Lexapro) for the Treatment of Postpartum Depression (NCT NCT00833469)

Last Updated: 2014-08-06

Results Overview

The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

8 weeks

Results posted on

2014-08-06

Participant Flow

Seven subjects were enrolled in this study. Prior to receiving treatment, two subjects were found to be ineligible per protocol eligibility requirements.

Participant milestones

Participant milestones
Measure	Escitalopram Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Escitalopram Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Escitalopram (Lexapro) for the Treatment of Postpartum Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=4 Participants Flexible dose escitalopram 10mg Escitalopram: Once daily by mouth
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.

Outcome measures

Outcome measures
Measure	Escitalopram n=3 Participants Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)	-21.33 units on a scale Standard Deviation 11.24

SECONDARY outcome

Timeframe: 8 weeks

Population: Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.

The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \>9 is indicative of perinatal major depression.

Outcome measures

Outcome measures
Measure	Escitalopram n=3 Participants Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Change in Edinburgh Postnatal Depression Scale (EPDS)	-19.33 units on a scale Standard Deviation 2.52

SECONDARY outcome

Timeframe: 8 weeks

Population: Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.

Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).

Outcome measures

Outcome measures
Measure	Escitalopram n=3 Participants Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Change in Beck Anxiety Inventory (BAI)	-15.00 units on a scale Standard Deviation 9.85

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Escitalopram n=3 participants at risk Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Gastrointestinal disorders Nausea	66.7% 2/3 • 32 months
Nervous system disorders Decreased sleep	33.3% 1/3 • 32 months
Musculoskeletal and connective tissue disorders Jaw tightness	33.3% 1/3 • 32 months
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • 32 months
Reproductive system and breast disorders Vaginal discharge	33.3% 1/3 • 32 months

Additional Information

Dr. Marlene Freeman, MD

Massachusetts General Hospital

Phone: 617-643-6403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place