Trial Outcomes & Findings for A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women (NCT NCT04094870)

NCT ID: NCT04094870

Last Updated: 2021-11-10

Results Overview

In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 80 participants
• Primary outcome timeframe: 2-7 weeks postpartum
• Results posted on: 2021-11-10

Participant Flow

Participant milestones

Measure	Antidepressant Medication Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg)	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Overall Study STARTED	40	40
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Antidepressant Medication Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg)	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Baseline characteristics by cohort

Measure	Antidepressant Medication n=40 Participants Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg)	Interpersonal Therapy n=40 Participants Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period	Total n=80 Participants Total of all reporting groups
Age, Continuous	29.5 years STANDARD_DEVIATION 5.5 • n=5 Participants	30.0 years STANDARD_DEVIATION 5.3 • n=7 Participants	29.7 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Zambia	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-7 weeks postpartum

In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum

Outcome measures

Measure	Approached Patients n=240 Participants Eligible patients approached for participation	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women Approached Who Agreed to Pre-Screening With EPDS	240 Participants	—

PRIMARY outcome

Timeframe: 2-7 weeks postpartum

The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of >/= 6 is indicative of a woman being at risk of perinatal depression. The number of women with an EPDS >/= 6 out of all of the women who were pre-screened with an EPDS.

Outcome measures

Measure	Approached Patients n=240 Participants Eligible patients approached for participation	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women Pre-Screened Who Have an EPDS Score >/= 6	199 Participants	—

PRIMARY outcome

Timeframe: 2-7 weeks postpartum

Population: 199 women were eligible for the MINI based on an EPDS \>/= 6.

MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment. After pre screening with an EPDS, women with an EPDS >/=6 were invited to undergo MINI diagnostic testing after signed consent.

Outcome measures

Measure	Approached Patients n=199 Participants Eligible patients approached for participation	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI	120 Participants	—

PRIMARY outcome

Timeframe: 6-8 weeks postpartum

Population: 91 met diagnostic criteria by MINI.

MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment.

Outcome measures

Measure	Approached Patients n=91 Participants Eligible patients approached for participation	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study	80 Participants	—

PRIMARY outcome

Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

Number of women who are enrolled in the study who complete the final study visit

Outcome measures

Measure	Approached Patients n=40 Participants Eligible patients approached for participation	Interpersonal Therapy n=40 Participants Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women Retained in the Study	39 Participants	39 Participants

SECONDARY outcome

Timeframe: Enrollment - final study visit, approximately 24 weeks after enrollment

The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of > 6 is indicative of a woman being at risk of perinatal depression.

Outcome measures

Measure	Approached Patients n=39 Participants Eligible patients approached for participation	Interpersonal Therapy n=39 Participants Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women With an EPDS Score Decline of 3 Points From Baseline	37 Participants	39 Participants

SECONDARY outcome

Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

The Clinical Global Impression (CGI) is a 7-point scale (range 1-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with the patient. Lower scores correlate with clinical improvement.

Outcome measures

Measure	Approached Patients n=39 Participants Eligible patients approached for participation	Interpersonal Therapy n=39 Participants Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women With a CGI Score Decline of One Point From Baseline	38 Participants	39 Participants

SECONDARY outcome

Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity

Outcome measures

Measure	Approached Patients n=40 Participants Eligible patients approached for participation	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Percentage of Women Experiencing Anti Depressant Medication Toxicity	0 percentage of women who discontinued	—

SECONDARY outcome

Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report

Outcome measures

Measure	Approached Patients n=40 Participants Eligible patients approached for participation	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)	14 percentage of participants	—

SECONDARY outcome

Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

Number of women randomized to the IPT arm who complete all IPT sessions

Outcome measures

Measure	Approached Patients n=40 Participants Eligible patients approached for participation	Interpersonal Therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)	5 Participants	—

SECONDARY outcome

Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

Participants completed a satisfaction survey at the final study visit addressing issues around 4 topics: (1) satisfaction with the study; (2) satisfaction with the intervention received; (3) self-perceived improvement of mental health; and (4) preference for study intervention not received. Responses were recorded using a Likert-type rating scale with the following responses: "Strongly disagree", "disagree", "neutral", "agree", and "strongly agree". For analysis purposes responses were combined into categories as follows: Agree and Strongly Agree, Disagree and Strongly Disagree, and neutral.

Outcome measures

Measure	Approached Patients n=39 Participants Eligible patients approached for participation	Interpersonal Therapy n=39 Participants Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Acceptability of Trial Participation for Treatment of Postpartum Depression Satisfaction with the study: Strongly Agree or Agree	39 Participants	39 Participants
Acceptability of Trial Participation for Treatment of Postpartum Depression Satisfaction with the intervention received: Strongly Agree or Agree	37 Participants	37 Participants
Acceptability of Trial Participation for Treatment of Postpartum Depression Satisfaction with the intervention received: Strongly Disagree or Disagree	2 Participants	2 Participants
Acceptability of Trial Participation for Treatment of Postpartum Depression Self-perceived improvement of mental health: Strongly Agree or Agree	39 Participants	39 Participants
Acceptability of Trial Participation for Treatment of Postpartum Depression Preference for study intervention not received: Strongly Agree or Agree	6 Participants	4 Participants
Acceptability of Trial Participation for Treatment of Postpartum Depression Preference for study intervention not received: Neutral	10 Participants	16 Participants
Acceptability of Trial Participation for Treatment of Postpartum Depression Preference for study intervention not received: Strongly Disagree or Disagree	23 Participants	19 Participants

SECONDARY outcome

Timeframe: Enrollment - final visit, approximately 24 weeks after enrollment

The mean change in the viral load will be measured between all women enrolled between the first and last visits

Outcome measures

Measure	Approached Patients n=39 Participants Eligible patients approached for participation	Interpersonal Therapy n=39 Participants Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Changes in the Viral Load Between Study Entry and the Last Visit	0.6 log copies/mL Standard Deviation 4.0	1.6 log copies/mL Standard Deviation 3.7

Adverse Events

Antidepressant Medication

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Interpersonal Therapy

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Antidepressant Medication n=40 participants at risk Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg)	Interpersonal Therapy n=40 participants at risk Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
Gastrointestinal disorders Mild Medication Toxicity - Gastrointestinal	7.5% 3/40 • Number of events 3 • From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months.	0.00% 0/40 • From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months.
Psychiatric disorders Suicidal Ideation	5.0% 2/40 • Number of events 2 • From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months.	22.5% 9/40 • Number of events 9 • From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months.
Nervous system disorders Mild medication toxicity - Central nervous system	10.0% 4/40 • Number of events 4 • From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months.	0.00% 0/40 • From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months.

Additional Information

Elizabeth Stringer, MD, MSc

University of North Carolina at Chapel Hill

Phone: 919-966-1601

Email: elizabeth_stringer@med.unc.edu

Results disclosure agreements

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