Trial intelligence / Profile preview

Pilot Trial of Sertraline vs IPT for Perinatal Depression in HIV+ Women

NCT04094870Phase 4

Key facts

Status: Completed
Start: Oct 2019
Primary completion: Oct 2020
Countries: 1
Sponsor: University of North Carolina at Chapel Hill
Modality: Small Molecules

Drugs: sertraline
Conditions: Perinatal depression (PPD)

Overview

Phase 4, randomised, open-label trial of sertraline in Perinatal depression (PPD) (2 arms), sponsored by University of North Carolina at Chapel Hill. Primary endpoints: Number of Women Approached Who Agreed to Pre-Screening With EPDS, Number of Women Pre-Screened Who Have an EPDS Score >/= 6 and 3 more. Started Oct 2019; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Antidepressant medication
Daily Sertraline 25 mg
Interpersonal therapy
Up to 11 therapy sessions

Who it enrols

Postpartum women (6-8 weeks) with confirmed HIV-1 infection and a diagnosis of perinatal depression, currently on ART, and not actively suicidal.

Endpoints

Primary

Number of Women Approached Who Agreed to Pre-Screening With EPDS2-7 weeks postpartum
Number of Women Pre-Screened Who Have an EPDS Score >/= 62-7 weeks postpartum
Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI2-7 weeks postpartum
Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study6-8 weeks postpartum
Number of Women Retained in the Study24 weeks

Secondary

Number of Women With an EPDS Score Decline of 3 Points From Baseline24 weeks
Number of Women With a CGI Score Decline of One Point From Baseline24 weeks
Percentage of Women Experiencing Anti Depressant Medication Toxicity24 weeks
Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)24 weeks
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)24 weeks
Acceptability of Trial Participation for Treatment of Postpartum Depression24 weeks
Changes in the Viral Load Between Study Entry and the Last Visit24 weeks

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