An interventional study of Melodies for Mums to Be and Usual Care in Antenatal Depression, sponsored by King's College London. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by King's College London · Not applicable, Interventional, and Treatment
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Among 32 studies in Depression by King's College London — 5 open to participants now, 8 under way, none of them phase 3. Depression · King's College London.
Among the 32 studies in Depression by King's College London, this one is the 12th largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2027, is one of 22 with no phase, and was the 32nd registered.
8,590 studies on the registry are indexed under Depression; 1,728 are open to participants now.
Browse Depression studies →5 of the 32 studies in Depression by King's College London are open now, in 1 country. Recruiting first, the newest first:
King's College London · Sites in United Kingdom
Ages 40–55 · Women only · Healthy volunteers
King's College London · Sites in United Kingdom
Ages 18+
King's College London · Sites in United Kingdom
Ages 18+
King's College London
Ages 18+
By country, each count listing its studies:
Of the 1,090 Depression studies recruiting now, 470 (43%) set no upper age limit and 520 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 2
First in 2003; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 50 is below the median of 81 across 7,074 interventional studies indexed under Depression.
Median enrollment 50 across the 25 interventional studies, 170 across the 7 observational. Of the 22 that completed or were terminated, 2 (9%) have results posted.
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King's College London is the lead sponsor of 521 studies on the registry; 127 are open to participants now.
1 of the studies in Depression by King's College London that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07599930King's College LondonImpact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being | 2026-12 |
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Among the 32 studies in Depression by King's College London, from their registry updates:
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Antenatal depression (AND) is a common mental health condition, affecting approximately 1 in 10 expectant mothers, yet many find it difficult to access the right kind of support. Feeling low during pregnancy can affect day-to-day wellbeing and is associated with difficulties in feeling connected to the unborn baby and to others around them. If left unsupported, AND can have wider consequences, including an increased risk of preterm birth, difficulties in the developing relationship between mother and baby, and effects on the child's development after birth.
Group singing may offer an accessible, non-clinical way to support mental health during pregnancy, providing a friendly, non-judgemental space in which to meet others and take part in a shared activity. This study builds on research from the Melodies for Mums programme, which showed that community group singing reduced symptoms of depression and improved the relationship between mothers and their babies after birth. This study aims to investigate whether a similar programme, Melodies for Mums to Be, delivered during pregnancy, can reduce symptoms of depression, improve mood and wellbeing, and support the relationship between expectant mothers and their unborn babies. The study is funded by the Psychiatry Research Trust and delivered by King's College London in partnership with Breathe Arts Health Research.
Fifty expectant mothers aged 18 or over who are experiencing symptoms of low mood (a score of 10 or above on the Edinburgh Postnatal Depression Scale) will be recruited from across London from 16 weeks' gestation. Participants will be randomly allocated either to attend a six-week group singing programme during pregnancy or to receive the same programme after the birth of their baby, ensuring that all participants have the opportunity to take part. Sessions will last approximately 60 minutes, be held weekly at community cultural venues across London, and be led by trained facilitators. No musical experience is needed.
Participants will complete questionnaires and interviews before, during, and after the programme, and at approximately 8 weeks, 7 months, and 12 months after giving birth. The main outcome is the change in depressive symptoms over the six-week programme period, compared between the two groups. Participants who consent will also provide saliva and blood samples to help understand whether singing during pregnancy is associated with changes in biological markers of stress and bonding.
Antenatal depression (AND) affects approximately 10-20% of pregnant women and represents a significant public health concern with implications for both maternal wellbeing and infant development. AND has been associated with adverse outcomes including increased risk of preterm birth, low birth weight, and altered infant stress regulation. Early identification and support for women experiencing depressive symptoms during pregnancy is therefore critical for both maternal and infant health.
One potential pathway linking depression during pregnancy to later developmental outcomes is maternal-foetal attachment, defined as the emotional bond a pregnant woman develops with her unborn baby. Lower levels of maternal-foetal attachment have been associated with greater severity of depressive symptoms during pregnancy. Singing interventions have been associated with improvements in mood, reductions in stress-related biomarkers such as cortisol, and enhanced feelings of social connection. However, many existing studies have been conducted in community samples where participants report relatively low levels of psychological distress at baseline, meaning limited evidence exists regarding the effectiveness of such interventions for women experiencing clinically meaningful depressive symptoms during pregnancy.
In the postnatal period, the SHAPER-PND Melodies for Mums (M4M) clinical trial demonstrated reductions in depressive symptoms and improvements in mother-infant interaction and maternal communication towards the infant. However, most existing research has focused on postnatal interventions, and relatively little work has explored whether similar approaches are beneficial when delivered during pregnancy, particularly among women experiencing antenatal depression. Building on the evidence generated through the SHAPER-PND trial, the present study aims to evaluate the effectiveness of adapting a community group singing intervention for delivery during pregnancy among women experiencing antenatal depressive symptoms.
Trial design and aims: The Melodies for Mums to Be (M4M2B) study will be conducted by King's College London in collaboration with Breathe Arts Health Research. The study will use a two-arm randomised delayed-access design, whereby all eligible participants will be offered the M4M2B intervention; the immediate access arm during pregnancy, and the delayed access arm postnatally following completion of the 8-week postpartum assessment. The intervention consists of six weekly group singing sessions delivered in community cultural venues across London, in groups of up to 15 participants. Eligibility screening will be offered from 16 weeks' gestation onwards, and the intervention will usually commence between 20+0 and 28+6 weeks of gestation. Participants will be assessed at six timepoints: baseline, midpoint (week 3-4), post-intervention (week 6-8), and approximately 8 weeks, 7 months, and 12 months postpartum. At baseline and post-intervention, participants will attend an in-person visit to the NIHR Clinical Research Facility at King's College Hospital for a video-recorded guided interaction task with the unborn baby (Prenatal Marschak Interaction Method; Prenatal MIM) and, for those who consent, blood and saliva sample collection. All other assessments will be routinely carried out online, either as a video call on Microsoft Teams for interviews or through online surveys via REDCap. Individual participants will be involved in the study from enrolment to their final 12-month postpartum follow-up.
The study will evaluate the clinical effectiveness of the intervention in reducing depressive symptoms and improving maternal-foetal attachment and interaction quality, as well as different aspects of maternal mental health including anxiety, perceived stress, and emotion regulation. The study will also evaluate the implementation effectiveness of the intervention, including its uptake, acceptability, appropriateness and feasibility.
Participants and Recruitment process: The study aims to recruit 50 pregnant women. Recruitment will be primarily carried out through: recruitment via SLaM, through signposting and awareness within relevant community services; social media and community outreach, including online groups, forums, and local community publicity, aimed at pregnant people and parents; publicity in healthcare settings, including posters and flyers displayed in GP practices and other relevant antenatal services or clinics; antenatal education and community spaces, including antenatal classes, Children and Family Centres, and local newsletters/mailing lists; and self-referral. Potential participants will be directed to a registration form on Breathe's website. When a place becomes available and the participant is within the relevant gestational window, they will be invited to complete the Edinburgh Postnatal Depression Scale (EPDS) online to assess depressive symptoms. Those scoring 10 or above will be considered eligible. Eligible participants will then be contacted by the KCL research team, provided with the full Participant Information Sheet, and given at least 24 hours to consider participation before completing the full informed consent process. Following completion of baseline assessments required for randomisation, participants will be randomised (1:1) in REDCap.
Measures and Procedures: Measures will be collected from study participants at six timepoints during the study.
Implementation measures (Acceptability of Intervention Measure, AIM; Intervention Appropriateness Measure, IAM; Feasibility of Intervention Measure, FIM) will be collected during the intervention phase only, for the immediate access arm antenatally and for the delayed access arm postnatally, and from both arms at 12 months postpartum. Biological samples will be collected from participants who consent to biological sample collection. All recordings will be coded by trained coders using validated scales (Prenatal MIM; CARE-Index; PCAMS), blind to participant allocation where possible.
Collection, transportation and storage of samples: Diurnal saliva samples consisting of six samples will be collected by participants at home at awakening, at 15, 30, and 60 minutes post-awakening, at midday, and at 8pm, in relation to Session 1 and Session 6 of the singing programme, and at the 8-week and 12-month postpartum assessments. Infant saliva samples consisting of two samples will be collected by parents at home using SalivaBio Infant Swabs at the 8-week and 12-month postpartum assessments. Pre- and post-session saliva and passive drool samples will be collected on site immediately before and after Session 1 and Session 6. Blood samples will be collected by a trained phlebotomist at the NIHR Clinical Research Facility at King's College Hospital at baseline and post-intervention. Samples will be stored at the Maurice Wohl Clinical Neuroscience Institute, King's College London (diurnal samples at -20°C; pre-post session, passive drool and blood samples at -80°C) and used for cortisol, oxytocin, cytokines, and other stress-related biomarker and hormonal analyses. Results will be identified according to anonymised participant codes and stored securely.
Follow-up: Follow-up with all participants will be conducted at approximately 8 weeks, 7 months, and 12 months postpartum. Participants' wellbeing will be monitored through the questionnaires, and any concerns will be flagged to the designated safeguarding lead.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomised to the immediate access arm will receive immediate antenatal access to the six-week group singing intervention, offered alongside existing care.
Behavioral: Melodies for Mums to Be
Participants randomised to the delayed access arm will not attend antenatal singing sessions and will receive usual care during pregnancy. They will complete the same antenatal assessment schedule as participants in the immediate access arm. The delayed access arm will be offered the same six-week singing intervention postnatally, commencing after completion of the 8-week postpartum assessment.
Behavioral: Melodies for Mums to Be · Other: Usual Care
Melodies for Mums to Be (M4M2B) is a community-based group singing intervention delivered by Breathe Arts Health Research, based on the Melodies for Mums model. The intervention consists of six weekly group singing sessions delivered in community cultural venues across London, in groups of up to 15 participants. Sessions last approximately 60 minutes and are facilitated by trained Breathe artists with experience delivering perinatal singing interventions. Each session includes guided group singing, breathing and relaxation exercises, and opportunities for informal peer interaction. The repertoire is designed to be accessible regardless of musical experience and may include songs drawn from diverse cultural and musical traditions. Sessions are facilitated in English throughout.
Also known as: M4M2B
Participants will receive usual care during pregnancy.
Change in depressive symptoms (Edinburgh Postnatal Depression Scale, EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire developed to detect depression in the perinatal period, and is validated for use in pregnancy. For each statement, women choose one of four responses that best describes how they have felt over the past week. Each item is scored 0 to 3; total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.
Time frame: From baseline (before the first session) to post-intervention (week 6 to 8)
Change in maternal-foetal attachment (Maternal Antenatal Attachment Scale, MAAS)
The Maternal Antenatal Attachment Scale (MAAS) is a 19-item self-report questionnaire assessing a pregnant woman's thoughts and feelings towards her unborn baby, covering the quality of attachment and the intensity of preoccupation with the baby. Total scores range from 19 to 95, with higher scores indicating stronger maternal antenatal attachment.
Time frame: Baseline (before the first session), midpoint (week 3 to 4) and post-intervention (week 6 to 8)
Change in maternal-foetal interaction quality (Prenatal Marschak Interaction Method, Prenatal MIM)
The Prenatal Marschak Interaction Method (Prenatal MIM) is a 15-20 minute video-recorded observational assessment in which the mother completes a series of structured tasks directed at her unborn baby (e.g., talking to, touching and singing to the baby). Recordings are coded by trained coders using the Emotional Availability Pregnancy Screener (Emotional Availability Scales, 4th edition). Two dimensions are rated: Sensitivity (e.g., affect, responsiveness to the baby, bodily attunement, acceptance and amount of interaction) and Non-hostility (e.g., absence of negativity, disrespectful remarks or hostile themes). Each dimension is scored from 1 to 7, with higher scores indicating greater maternal sensitivity and lower hostility towards the unborn baby.
Time frame: Baseline (before the first session) and post-intervention (week 6 to 8)
Change in depressive symptoms (EPDS) across all study timepoints
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire measuring depressive symptoms. Each item is scored 0 to 3; total scores range from 0 to 30, with higher scores indicating more severe symptoms. Change is assessed across all study timepoints.
Time frame: Baseline (before the first session), midpoint (week 3 to 4), post-intervention (week 6 to 8), and approximately 8 weeks, 7 months and 12 months postpartum
Change in depressive symptoms (Patient Health Questionnaire, PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire based on the diagnostic criteria for major depression. Respondents rate how often they have been bothered by each symptom over the past two weeks, from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline (before the first session), midpoint (week 3 to 4), post-intervention (week 6 to 8), and approximately 8 weeks, 7 months and 12 months postpartum
Change in anxiety symptoms (Generalised Anxiety Disorder 7-Item, GAD-7)
The Generalised Anxiety Disorder 7-Item Scale (GAD-7) is a 7-item self-report questionnaire measuring symptoms of generalised anxiety. Respondents rate how often they have been bothered by each symptom over the past two weeks, from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline (before the first session), midpoint (week 3 to 4), post-intervention (week 6 to 8), and approximately 8 weeks, 7 months and 12 months postpartum
Change in perceived stress (Perceived Stress Scale, PSS)
The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire measuring the degree to which situations in one's life over the past month are appraised as unpredictable, uncontrollable and overloading. Each item is rated from 0 (never) to 4 (very often), with positively worded items reverse-scored. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Time frame: Baseline (before the first session), post-intervention (week 6 to 8), and approximately 8 weeks, 7 months and 12 months postpartum
Change in emotion regulation (Difficulties in Emotion Regulation Scale - Short Form 16, DERS-16)
The Difficulties in Emotion Regulation Scale - Short Form (DERS-16) is a 16-item self-report questionnaire assessing difficulties in emotion regulation, including emotional clarity, acceptance of emotional responses, impulse control, goal-directed behaviour when distressed and access to effective regulation strategies. Each item is rated from 1 (almost never) to 5 (almost always). Total scores range from 16 to 80, with higher scores indicating greater difficulties in emotion regulation.
Time frame: Baseline (before the first session), post-intervention (week 6 to 8), and approximately 8 weeks and 12 months postpartum
Change in body image during pregnancy (Body Understanding Measure for Pregnancy Scale, BUMPS)
The Body Understanding Measure for Pregnancy Scale (BUMPS) is a 19-item self-report questionnaire measuring body image during pregnancy across three subscales: satisfaction with appearing pregnant, concerns about weight gain and the physical burden of pregnancy. Total scores range from 19 to 95, with higher scores indicating greater body dissatisfaction.
Time frame: Baseline (before the first session), midpoint (week 3 to 4) and post-intervention (week 6 to 8)
Change in perceived social support (Multidimensional Scale of Perceived Social Support, MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report questionnaire measuring perceived support from family, friends and a significant other. Each item is rated from 1 (very strongly disagree) to 7 (very strongly agree). Total scores range from 12 to 84, with higher scores indicating greater perceived social support.
Time frame: Baseline (before the first session), post-intervention (week 6 to 8), and approximately 8 weeks, 7 months and 12 months postpartum
Acceptability of the intervention (Acceptability of Intervention Measure, AIM)
The Acceptability of Intervention Measure (AIM) is a 4-item self-report implementation outcome measure assessing how acceptable participants find the intervention. Each item is rated from 1 (completely disagree) to 5 (completely agree), and the score is the mean of the items, ranging from 1 to 5, with higher scores indicating greater acceptability. Collected during the intervention phase only (antenatally for the immediate access arm; postnatally for the delayed access arm), and from both arms at 12 months postpartum.
Time frame: Programme midpoint and end; approximately 8 weeks postpartum (immediate access arm only); approximately 12 months postpartum
Appropriateness of the intervention (Intervention Appropriateness Measure, IAM)
The Intervention Appropriateness Measure (IAM) is a 4-item self-report implementation outcome measure assessing how appropriate (fitting, suitable) participants find the intervention. Each item is rated from 1 (completely disagree) to 5 (completely agree), and the score is the mean of the items, ranging from 1 to 5, with higher scores indicating greater appropriateness. Collected during the intervention phase only (antenatally for the immediate access arm; postnatally for the delayed access arm), and from both arms at 12 months postpartum.
Time frame: Programme midpoint and end; approximately 8 weeks postpartum (immediate access arm only); approximately 12 months postpartum
Feasibility of the intervention (Feasibility of Intervention Measure, FIM)
The Feasibility of Intervention Measure (FIM) is a 4-item self-report implementation outcome measure assessing how feasible (workable, possible to take part in) participants find the intervention. Each item is rated from 1 (completely disagree) to 5 (completely agree), and the score is the mean of the items, ranging from 1 to 5, with higher scores indicating greater feasibility. Collected during the intervention phase only (antenatally for the immediate access arm; postnatally for the delayed access arm), and from both arms at 12 months postpartum.
Time frame: Programme midpoint and end; approximately 8 weeks postpartum (immediate access arm only); approximately 12 months postpartum
Uptake/reach of the intervention
Number of eligible participants who sign up to the intervention.
Time frame: Throughout the recruitment period
Intervention adherence and attrition
Number of participants adhering to the intervention and drop-outs measured weekly.
Time frame: Weekly during the six-week intervention
Maternal diurnal salivary cortisol
Maternal salivary cortisol concentration (nmol/L), measured by immunoassay in saliva samples collected at home using Salivettes at six points across one day: at awakening, 15, 30 and 60 minutes after awakening, at midday and at 8pm, to characterise the diurnal cortisol profile. Collected from participants who consent to biological sampling.
Time frame: Week 1 and week 6 of the intervention (around Session 1 and Session 6); approximately 8 weeks and 12 months postpartum
Infant diurnal salivary cortisol
Infant salivary cortisol concentration (nmol/L), measured by immunoassay in saliva samples collected at home by the mother using infant swabs at two points across one day: at awakening and at 8pm. Collected from infants of participants who consent to infant biological sampling.
Time frame: Approximately 8 weeks and 12 months postpartum
Pre-post session maternal salivary cortisol
Maternal salivary cortisol concentration (nmol/L), measured by immunoassay in saliva samples (Salivette) collected on site immediately before and immediately after the singing session. Collected during the intervention phase only (antenatally for the immediate access arm; postnatally for the delayed access arm).
Time frame: Immediately before and immediately after Session 1 (week 1) and Session 6 (week 6) of the intervention
Pre-post session maternal salivary oxytocin
Maternal salivary oxytocin concentration (pg/mL), measured by immunoassay in passive drool saliva samples collected on site immediately before and immediately after the singing session. Collected during the intervention phase only (antenatally for the immediate access arm; postnatally for the delayed access arm).
Time frame: Immediately before and immediately after Session 1 (week 1) and Session 6 (week 6) of the intervention
Postnatal maternal attachment (Maternal Postnatal Attachment Scale, MPAS)
The Maternal Postnatal Attachment Scale (MPAS) is a 19-item self-report questionnaire assessing a mother's thoughts and feelings towards her infant, covering the quality of attachment, absence of hostility and pleasure in interaction. Total scores range from 19 to 95, with higher scores indicating stronger maternal attachment to the infant.
Time frame: Approximately 8 weeks, 7 months and 12 months postpartum
Mother-infant interaction quality (Crittenden Child-Adult Relationship Experimental Index, CARE-Index)
The Crittenden Child-Adult Relationship Experimental Index (CARE-Index) is a validated observational tool for assessing parent-infant interaction. A 3-minute video recording of the mother and baby in free play is coded by trained coders. The interaction is rated on scales of 0 to 14 for maternal behaviour (sensitivity, control and unresponsiveness), infant behaviour (cooperation, compulsivity, difficultness and passivity) and dyadic synchrony. Higher maternal sensitivity, infant cooperation and dyadic synchrony scores indicate more attuned interaction; higher maternal control and unresponsiveness, and higher infant compulsivity, difficultness and passivity scores indicate less attuned interaction.
Time frame: Approximately 8 weeks and 12 months postpartum
Maternal communication during mother-infant interaction (Parental Cognitive Attributions and Mentalization Scale, PCAMS)
The Parental Cognitive Attributions and Mentalization Scale (PCAMS) is a validated tool for assessing the quality of parental communication. Maternal speech during a 3-minute video recording of the mother and baby in free play is coded by trained coders, across three domains: mentalising comments (the mother's awareness and interpretation of her infant's cognitive, emotional and physiological states); attentional focus (infant-, parent- or other-focused speech); and affective connotation (positive or negative comments). Each category is reported as a proportion (0 to 100%) of maternal comments. Higher proportions of mentalising and infant-focused comments indicate more sensitive, supportive communication; higher proportions of negative or parent-focused comments indicate less sensitive communication.
Time frame: Approximately 8 weeks and 12 months postpartum
Change in couple relationship satisfaction (Couple Satisfaction Index - Short Form, CSI-16)
The Couple Satisfaction Index - Short Form (CSI-16) is a 16-item self-report questionnaire measuring satisfaction with a romantic relationship, including happiness, warmth and closeness in the relationship. Total scores range from 0 to 81, with higher scores indicating greater relationship satisfaction.
Time frame: Baseline (before the first session), post-intervention (week 6 to 8), and approximately 8 weeks and 12 months postpartum
Parenting stress (Parenting Stress Index, Fourth Edition Short Form, PSI-4-SF)
The Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) is a 36-item self-report questionnaire measuring stress within the parent-child system across three subscales: parental distress, parent-child dysfunctional interaction and difficult child. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). Total stress scores range from 36 to 180, with higher scores indicating greater parenting stress.
Time frame: Approximately 8 weeks and 12 months postpartum
Plan to share: Yes — Anonymised data sets will be made available on the KCL Research Data Management System. Protocol will be published in a peer-reviewed journal.
Supporting information: Study protocol
Time frame: Following publication of the main study results.
Access criteria: Requests to access the anonymised data can be made to the research team, and access will be granted only for ethically approved research studies.
Start is estimated for Jan 2027; primary completion for Mar 2028, 14 months later.
Of 3,476 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 14 months is below that.
Counting every sponsor, half of 3,574 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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