Depression, Postpartum

11

Review clinical trials related to Depression, Postpartum. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Bed Rest With a Short Cervix on Preterm Birth

Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily. The use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects. The overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR). The primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix. Secondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density. Through the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \< 25 mm in singleton pregnancies and \< 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria. The primary outcome is gestational age in days (continuous).

Participants needed: 6,000
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Julie GlavindUpdated: May 11, 2026
Eligibility criteria

Cervical length < 25 mm in singleton pregnancies and < 30 mm in multiple pregnan... [+2]

Status: Recruiting

Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi

The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.

Participants needed: 400
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of North Carolina, Chapel HillUpdated: Apr 29, 2026Locations: 5
Eligibility criteria

Presenting for antenatal care at one of our 5 recruitment sites [+5]

Suicidal ideation evaluated as acute risk. [+1]

Status: Recruiting

Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression

The purpose of the study is to determine if access to a text-message based holistic chatbot support program "Healing at Home 2.0" decreases depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) compared to usual postpartum care for patients of color.

Participants needed: 156
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of PennsylvaniaUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Postpartum patients who have delivered a singleton baby at or after 37w0d at the... [+6]

Unable to provide informed consent [+2]

Status: Recruiting

Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father

In recent years, fatherhood has changed considerably. Fathers are now more involved during the perinatal period, with their partner but also in caring for the child. Investigators now know that this period is also a source of major psychological upheaval, identity crisis, apprehension and anxiety for men. These upheavals can lead to depression that must be detected and treated as early as possible. This is an easy screening to perform using the EPDS (Edinburgh Postnatal Depression Scale). Currently, the EPDS is the most widely used self-questionnaire to assess the risk of depression in women during the perinatal period. Indeed, it is systematically recommended in many countries. It is starting to be used for the same purpose in the perinatal period in men, although the scale has not been validated in a representative sample of men in the pre- or post-natal period. The main objective is to validate the use of the EPDS scale as a screening tool for postnatal depression in a population of French fathers. They complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Groupe Hospitalier du HavreUpdated: Jan 21, 2026Locations: 2
Eligibility criteria

All fathers whose baby is 10 days old or less

People with a poor understanding of spoken or written French [+2]

Status: Recruiting

From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health

Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo/treatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health/disease process.

Participants needed: 150
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hospital de Clinicas de Porto AlegreUpdated: Dec 3, 2025Locations: 1
Eligibility criteria

4-6 weeks postpartum; [+2]

Active suicidal ideation; [+3]

Status: Recruiting

TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety

This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period.

Participants needed: 125
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: BlueSkeye AIUpdated: Sep 19, 2025Locations: 2
Eligibility criteria

Fluent in spoken and written English [+5]

● Current clinically diagnosed psychiatric disorder other than depression [+2]

Status: Recruiting

A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy

In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities. This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from CVS Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy. The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms. The main question researchers want to answer in this study is: \- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15? Researchers will also learn more about: * Changes in participants' EPDS scores from before treatment to Day 45, which is 30 days after treatment ends. * How many participants breastfeed their babies while taking zuranolone * How many participants do not start new medicine after finishing their zuranolone treatment * How many participants take new medicines after finishing zuranolone * How many participants already tried other medicines for their depression symptoms before joining this study * How many participants take other medicines in general while taking zuranolone This study will be done as follows: People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study. Those who agree to take part will answer written questions about their symptoms using the EPDS tool. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study. Participants will then be asked to answer questions using the EPDS tools, 15 days and 45 days after taking the first dose of zuranolone.

Participants needed: 200
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: BiogenUpdated: Aug 3, 2025Locations: 1
Eligibility criteria

Adults who were prescribed and had one successful fill for zuranolone within 12... [+2]

Prior fill of zuranolone or brexanolone in last 12 months. [+4]

Status: Recruiting

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: Jul 20, 2025Locations: 4
Eligibility criteria

Pregnant person carrying a fetus diagnosed with single ventricle congenital hear... [+4]

Fetus with comorbid condition with a predictable adverse impact on neurodevelopm... [+5]

Status: Recruiting

Implementation of a Psychoeducational Intervention in New Mothers

The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. Additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals. Researchers will compare "Usual Care" (standard postnatal care provided by professionals from the Sexual and Reproductive Health Service) with "Intervention group" (usual care plus two psychoeducative intervention WWWT sessions) to see if the "WWWT intervention" is better than "Usual Care" at preventing postpartum depression and anxiety disorders in new mothers. Participants will: * Take baseline questionnaires at 2-4 weeks postpartum * Take usual care or usual care plus two psychoeducative intervention WWWT sessions within the first 6 weeks postpartum * Take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up * Take a brief anonymous self-report survey (only those participants taking the WWWT intervention)

Participants needed: 400
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Alba RocaUpdated: Feb 26, 2025Locations: 2
Eligibility criteria

Primiparous women [+4]

If are unable to complete the questionnaires due to language or literacy barrier...

Status: Recruiting

Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools in the Perinatal Period.

It is known that 1 in 5 women experience psychological difficulties during their pregnancy or in the first year after giving birth. Unfortunately, in 75% of cases, these problems go undetected, resulting in the woman, her partner and the baby not receiving the proper care. For this reason, the Flemish government wants to screen all women in the perinatal period for their mental well-being using short questionnaires with the aim of referring them to appropriate care. Before they can recommend this screening to all women in the perinatal period, it is necessary to investigate the effectiveness of these short questionnaires, as well as the proposed stepped screening protocol. The investigators want to use this study to determine whether the questionnaires and the stepped screening protocol are sufficiently sensitive to detect mental health problems during this period. This means that they want to check whether the (future) moms who screen positive actually have problems and whether the (future) moms who screen negative effectively do not have psychological problems. In case of positive findings, teh investigators want to recommend that screening for psychological well-being should best be part of standard care in the future. Participants will be asked to answer some questions regarding depressive and anxiety symptoms using existing screening instruments (Whooley, GAD-2, EPDS and GAD-7). On the basis of an online application one can be assigned to the group that will be invited for a telephone interview by a study employee of the UZ Gent (psychologist or psyciatrist) to conduct a semi-structured interview within 2 weeks after completing these questions. The interviewer will ask questions about current psychological well-being and, where applicable, psychological problems in the past. The interviewer will not be aware of the responses to the questionnaires, so as not to be prejudiced. Being contacted for an interview does not necessarily mean that those women scored higher on the questionnaires, as they may also belong to the control group. In addition, a number of demographic data are requested (such as age, marital status, level of education, occupational category, how many pregnancies, number of other (living) children, (expected) delivery date, current forms of treatment (medications, psychotherapeutic interventions) and psychiatric history).

Participants needed: 1,800
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: University Hospital, GhentUpdated: Oct 30, 2024Locations: 2Duration: 2 Weeks
Eligibility criteria

18 years or older, antenatal period (20-24 th week of pregnancy) or postnatal pe...

<18 years, non-Dutch speaking and outside the above mentioned period.

Status: Recruiting

Evaluation of Access to Screening for Post-partum Depression Via the Postnatal Interview Within 8 Weeks of Birth in Women Who Have Gave Birth at the Troyes Hospital ( DEPRESSIONPP )

Post-partum depression is defined as a depressive disorder with onset of symptoms in the year following childbirth. Several international studies have reported a prevalence of this condition of around pathology of around 15%. Santé publique France's 2021 national perinatal survey corroborated these figures, finding a prevalence of post-partum depression in France of in France of 16.7%. It is therefore a frequent pathology that can cause complications for both mother and child. The complications both for the mother and for the mother-child bond. Indeed, post-partum depression can lead to an increased risk of infanticide, weaker mother-child attachment, and altered parental behaviour. post-partum depression can lead to maternal suicide (the second leading cause cause of maternal mortality in France). Despite the potential seriousness of severe depression and its impact on the on the mother-child bond, just under half of those suffering from severe depression suffering from severe depression consult a healthcare professional. Fear of being judged or stigmatised, linked to misperceptions about the episode, is one of the main obstacles to consultation. Of being judged or stigmatised, linked to erroneous representations of the depressive episode. Given the scale of this condition, and the difficulties young mothers face in seeking help for young mothers to seek help, it is vital to screen postpartum women as widely and post-partum women as early as possible. In view of the extent of this condition and the difficulties young mothers have in seeking help for young mothers, it is vital to screen post-partum women as widely and as post-partum. With this in mind, from July 2022, a compulsory early post-natal interview has been introduced, designed to screen for postpartum depression.

Participants needed: 400
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Centre Hospitalier de TroyesUpdated: Jun 21, 2024Locations: 1
Eligibility criteria

The study will include adult women who have given birth at the Centre hospitalie... [+4]