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Postnatal Depression clinical trials

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NCT ID: NCT06285916 Not yet recruiting - Clinical trials for Postpartum Depression

A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression

NuMom
Start date: February 2024
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine: - How well NORA520 is tolerated and what side effects it may cause - If NORA520 reduces depressive symptoms in subjects with severe PPD - The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken - In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.

NCT ID: NCT05148260 Not yet recruiting - Clinical trials for Postnatal Depression

Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for British Mothers of African and Caribbean Origin

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

By 2030, depression will be the leading global disease burden. Postnatal depression due to childbirth/parenting leads to long-term negative consequences for mothers, their children and their families. The British African/Caribbean communities are worse hit by the unprecedented impact of post-Covid-19-syndromes, leading to an exponential increase in postnatal depression. Yet, the uptake of mental healthcare by British mothers of African and Caribbean origin is low due to limited access to culturally appropriate care. Theories of attachment and cognitivism were innovatively integrated to examine Learning-Through-Play plus (LTP+) intervention for postnatal depression using a pilot randomised controlled trial. The proposed LTP+ is co-developed and ecologically friendly because it is manualised and can be delivered by non-mental health specialists such as trained community health workers who are more culturally knowledgeable. Findings will be disseminated through academic publications/presentations, policy briefs, original animated videos and podcast series laying the foundations for a psychosocial approach to tackling postnatal depression

NCT ID: NCT05046405 Not yet recruiting - Clinical trials for Postnatal Depression

Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study

4MUMs
Start date: October 2, 2022
Phase: N/A
Study type: Interventional

Postpartum Depression (PPD) is a Major Depressive (MD) Disorder occurring within the 12 months after delivery with negative effects to the mother, the child and the family and an estimated prevalence in Europe of 10-15%. Non-invasive Transcranial Direct Current Stimulation (tDCS) has been suggested to PPD, as it combines antidepressant effects with low risks, being equivalent to pharmacotherapy, and showing faster response than psychotherapy. tDCS uses a weak electric current applied to the scalp, modulating neurons' firing rate and neuroplasticity of cerebral circuits to counteract dysfunctional connectivity and inter-hemispheric imbalance in MD. tDCS portability led to its introduction as a home-based intervention and trials assessing home-based tDCS in MD were successful, proved its feasibility and showed good acceptance and benign effect in patients' self-efficacy. Hence, combining home-based tDCS with eHealth systems to support data collection and teleHealth for remote health care has shown positive results in other neuropsychiatric disorders. To uptake tDCS to PPD, further research is needed. To pursue the needed regulatory steps, current consensus on the primary hypothesis of efficacy is that future phase-III studies must be supported by the identification of biotypes of depression and should include cost-effectiveness analysis to model its economic advantage and inform Health Technology Analysis. 4MUMs, within an iterative user-centred and co-design approach will adopt a combined intervention (home-based tDCS + eHealth system + teleHealth system) for PPD, conduct a dynamic feasibility study of the data collection procedures and intervention, and test these in a single-arm pilot study towards the first large-sample multicentre Phase-III RCT protocol aimed at testing home-based tDCS efficacy in PPD.

NCT ID: NCT04644081 Not yet recruiting - Clinical trials for Postnatal Depression

LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria

LTP+CaCBT
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.

NCT ID: NCT04183582 Not yet recruiting - Clinical trials for Postnatal Depression

Behavioural Activation (BA) for Postnatal Depression in Blackpool

BA
Start date: December 2019
Phase: N/A
Study type: Interventional

Is Behavioural Activation feasible, acceptable and potentially effective for mothers experiencing post natal depression in Blackpool? Phase 1: A series of single case studies which aim to examine and refine a) the appropriateness of the programme to women in Blackpool b) the suitability of BA as part of a stepped-care approach to perinatal mental health within the Health Visitor pathway and c) the delivery of the programme in practice. Phase 2: A preliminary single group study examining the quantitative outcomes for participating women (i.e. symptoms of depression, anxiety and general mood, parental stress, responsiveness, and behavioural avoidance and activation.