Perinatal DepressionPhase 4NCT04094870
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
A Phase 4 study testing Sertraline and Interpersonal therapy in people with Perinatal Depression and HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 sites in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression, HIV-1-infection
- What is being tested?
- Sertraline and Interpersonal therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesZambia
- Study dates
- 30 Oct 2019to 30 Oct 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Kamwala District Health Centre
Lusaka
University Teaching Hospital
Lusaka
About this study
Official title: Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
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.
Read the detailed description
The standard of care for treating postpartum depression in the US is antidepressants, psychotherapy or both. Little data exist on the best method for treating perinatal depression (PND) in Sub-Saharan Africa. This is a mixed method study including a pilot randomized controlled trial (RCT) of antidepressant medication (ADM) versus interpersonal psychotherapy (IPT) and qualitative semi-structured interviews (SSIs). The study will enroll 100 pregnant HIV infected women over the age of 18 seeking postnatal care and continuing antiretroviral therapy in pregnancy. An additional 20 women enrolled in the RCT will be invited to participate in SSIs. Each participant will be followed for 24 weeks.
- Conditions
- Perinatal Depression, HIV-1-infection
- Being tested
- Sertraline, Interpersonal therapy
- Keywords
- perinatal depression, HIV, Antiretroviral Treatment, Interpersonal psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called SSRI
daily SSRI (Sertraline 25mg)
Interpersonal therapyBehavioural
11 sessions over a 24-week period
| Study group | Role | What they receive |
|---|---|---|
| Antidepressant medication | Active comparator | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Receives: Drug: Sertraline |
| Interpersonal therapy | Active comparator | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Receives: Behavioral: Interpersonal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Enrollment - final visit, approximately 24 weeks after enrollment
Secondary outcomes (7)
Number of Women With an EPDS Score Decline of 3 Points From Baseline
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.
Measured: Enrollment - final study visit, approximately 24 weeks after enrollment
Number of Women With a CGI Score Decline of One Point From Baseline
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.
Measured: Enrollment - final visit, approximately 24 weeks after enrollment
Percentage of Women Experiencing Anti Depressant Medication Toxicity
The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity
Measured: Enrollment - final visit, approximately 24 weeks after enrollment
Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report
Measured: Enrollment - final visit, approximately 24 weeks after enrollment
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
Number of women randomized to the IPT arm who complete all IPT sessions
Measured: Enrollment - final visit, approximately 24 weeks after enrollment
Acceptability of Trial Participation for Treatment of Postpartum Depression
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.
Measured: Enrollment - final visit, approximately 24 weeks after enrollment
Changes in the Viral Load Between Study Entry and the Last Visit
The mean change in the viral load will be measured between all women enrolled between the first and last visits
Measured: Enrollment - final visit, approximately 24 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start30 Oct 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stringer, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094870
- Sponsor's protocol ID
- 17-3411
- Other IDs
- 1R21MH115806, Z 31801
- Status last verified
- Dec 2020
- First submitted
- 16 Sep 2019
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
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.
PubMed 35803896
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
- ClinicalTrials.gov ID
- NCT04094870
- Acronym / sponsor ID
- 17-3411
- Conditions
- Perinatal Depression, HIV-1-infection
- Keywords
- perinatal depression, HIV, Antiretroviral Treatment, Interpersonal psychotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard of care for treating postpartum depression in the US is antidepressants, psychotherapy or both. Little data exist on the best method for treating perinatal depression (PND) in Sub-Saharan Africa. This is a mixed method study including a pilot randomized controlled trial (RCT) of antidepressant medication (ADM) versus interpersonal psychotherapy (IPT) and qualitative semi-structured interviews (SSIs). The study will enroll 100 pregnant HIV infected women over the age of 18 seeking postnatal care and continuing antiretroviral therapy in pregnancy. An additional 20 women enrolled in the RCT will be invited to participate in SSIs. Each participant will be followed for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Antidepressant medication | Active comparator | Drug: SertralineDaily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table |
| Interpersonal therapy | Active comparator | Behavioral: Interpersonal therapyUp to 11 planned therapy sessions over a 24-week period beginning the day of randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: SSRIdaily SSRI (Sertraline 25mg) | Drug | Antidepressant medication |
| Interpersonal therapy11 sessions over a 24-week period | Behavioural | Interpersonal therapy |
Primary outcome
Number of Women Approached Who Agreed to Pre-Screening With EPDS
Time frame: 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
Number of Women Pre-Screened Who Have an EPDS Score >/= 6
Time frame: 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.
Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI
Time frame: 2-7 weeks postpartum
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.
Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
Time frame: 6-8 weeks postpartum
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.
Number of Women Retained in the Study
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
Number of women who are enrolled in the study who complete the final study visit
7 secondary outcomes
Number of Women With an EPDS Score Decline of 3 Points From Baseline
Time frame: Enrollment - final study visit, approximately 24 weeks after enrollment
Number of Women With a CGI Score Decline of One Point From Baseline
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
Percentage of Women Experiencing Anti Depressant Medication Toxicity
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
Acceptability of Trial Participation for Treatment of Postpartum Depression
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
Changes in the Viral Load Between Study Entry and the Last Visit
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35803896Spelke 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Stringer, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline and Interpersonal therapy in people with Perinatal Depression and HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Women Approached Who Agreed to Pre-Screening With EPDS (time frame: 2-7 weeks postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.