A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

NCT04094870 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: 17-34111R21MH115806Z 31801
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study will evaluate, through quantitative and qualitative methods, whether different treatments for postpartum depression are feasible and acceptable in postpartum HIV infected women on antiretrovirals (ART). The study will take place at several clinics in Lusaka, Zambia.

Conditions

Perinatal Depression; HIV-1-infection

Keywords

perinatal depression; HIV; Antiretroviral Treatment; Interpersonal psychotherapy

Outcome Measures

Primary Outcomes (5)

• Number of Women Approached Who Agreed to Pre-Screening With EPDS

  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

  2-7 weeks postpartum

• Number of Women Pre-Screened Who Have an EPDS Score >/= 6

  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.

  2-7 weeks postpartum

• Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With 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. After pre screening with an EPDS, women with an EPDS \>/=6 were invited to undergo MINI diagnostic testing after signed consent.

  2-7 weeks postpartum

• Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study

  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.

  6-8 weeks postpartum

• Number of Women Retained in the Study

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

  Enrollment - final visit, approximately 24 weeks after enrollment

Secondary Outcomes (7)

• Number of Women With an EPDS Score Decline of 3 Points From Baseline

  Enrollment - final study visit, approximately 24 weeks after enrollment

• Number of Women With a CGI Score Decline of One Point From Baseline

  Enrollment - final visit, approximately 24 weeks after enrollment

• Percentage of Women Experiencing Anti Depressant Medication Toxicity

  Enrollment - final visit, approximately 24 weeks after enrollment

• Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)

  Enrollment - final visit, approximately 24 weeks after enrollment

• Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)

  Enrollment - final visit, approximately 24 weeks after enrollment

Study Arms (2)

Antidepressant medication

ACTIVE COMPARATOR

Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table

Drug: Sertraline

Interpersonal therapy

ACTIVE COMPARATOR

Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization

Behavioral: Interpersonal therapy

Interventions

Sertraline DRUG

daily SSRI (Sertraline 25mg)

Also known as: SSRI

Antidepressant medication

Interpersonal therapy BEHAVIORAL

11 sessions over a 24-week period

Interpersonal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Documentation of confirmed HIV-1 infection
• Six to eight weeks postpartum
• Currently taking ART treatment
• Able and willing to provide written informed consent
• Willing to adhere to study visit schedule
• PND diagnosis confirmed by Mini-International Neuropsychiatric Interview

You may not qualify if:

• Taking an ADM in the prior 12 months prior to enrollment
• Actively suicidal
• Known or suspected allergy or contraindication to first line Sertraline
• Any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Kamwala District Health Centre

Lusaka, Zambia

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (1)

• Spelke MB, Paul R, Blette BS, Meltzer-Brody S, Schiller CE, Ncheka JM, Kasaro MP, Price JT, Stringer JSA, Stringer EM. Interpersonal therapy versus antidepressant medication for treatment of postpartum depression and anxiety among women with HIV in Zambia: a randomized feasibility trial. J Int AIDS Soc. 2022 Jul;25(7):e25959. doi: 10.1002/jia2.25959.

  PMID: 35803896 DERIVED

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Elizabeth Stringer, MD, MSc
• Organization: University of North Carolina at Chapel Hill

elizabeth_stringer@med.unc.edu

919-966-1601

Study Officials

• Elizabeth Stringer, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline initial dose of 25 mg tablet versus IPT in a 1:1 ratio commenced between six and 8 weeks postpartum and continued through 30 weeks postpartum.

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: October 30, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 10, 2021
• Results First Posted: November 10, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: Investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.

Locations

ZA (2)