Bhopal

Researchers are evaluating the efficacy and safety of brenipatide combined with standard of care compared to placebo plus standard of care in delaying the worsening of symptoms in adults with bipolar disorder. This Phase 2, randomized, double-blind study aims to understand if brenipatide can help delay relapse in bipolar disorder patients. The study is sponsored by Eli Lilly and Company and focuses on adults aged 18 to 75 years diagnosed with bipolar disorder I or II. Participants will be randomly assigned to receive one of two doses of brenipatide or a placebo, each administered by subcutaneous injection alongside their standard of care medication. The trial is divided into three periods a screening period lasting about one month, a treatment period lasting at least six months, and a follow-up period lasting approximately two months. The total duration of participation may vary and can be shortened if symptoms worsen or if the participant withdraws. During the study, participants will self-inject the study medication, maintain study diaries, and complete questionnaires assessing their condition. Researchers will monitor time to relapse, changes in functional impairment, mood symptoms using specific rating scales, quality of life, patient global impressions, body weight, and pharmacokinetics. Safety will be closely observed, including the presence of treatment-emergent anti-drug antibodies. Participants are expected to attend regular visits throughout the treatment and follow-up periods.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.

This research aims to evaluate the effectiveness of a character-strengths based coaching program designed to reduce work-related stress and improve mental wellbeing among Accredited Social Health Activists ASHAs, who are rural female health workers in India. The study compares this coaching intervention to routine health worker supervision, focusing on self-reported wellbeing measured by the Authentic Happiness Inventory at three months. The trial also assesses other wellbeing indicators such as affect, self-efficacy, flourishing, burnout, and motivation, as well as service delivery and patient outcomes related to depression care. Participants are randomly assigned to one of two groups the intervention group receives a five-day residential workshop focused on character strengths and strategies to manage work stress, followed by 8 to 10 weeks of weekly telephonic coaching sessions. The control group continues with the usual weekly face-to-face supervision provided by their supervisors in group settings. The coaching sessions are individually delivered by assigned coaches via phone and last about 30 to 45 minutes each. During the study, participants will complete assessments at baseline, one month, three months, and six months to measure wellbeing and related factors. Data collection includes self-reported questionnaires on happiness, affect, burnout, and motivation. Researchers will also explore the impact of the intervention on work performance and patient satisfaction. Outcomes will be collected by assessors unaware of group assignments to ensure unbiased results. The total participation period includes multiple follow-ups to monitor both short- and medium-term effects.

Researchers are evaluating whether a deprescribing tool can help reduce prescriptions with potentially inappropriate medications PIMs among elderly patients in India. The study aims to determine if inappropriate polypharmacy can be lowered by developing and implementing a tool tailored to the Indian context, where medication use patterns differ from other countries. This trial compares outcomes between physicians who use the deprescribing tool and those who follow routine prescribing practices. In this multicenter study, physicians are randomly assigned to either a control group that prescribes as usual or an intervention group that uses the deprescribing tool during patient consultations. The tool guides medication review and deprescribing decisions, such as stopping duplicate drugs, tapering unnecessary medications, or reducing doses. Patients aged 60 years and older receive routine care from their assigned physician, and prescriptions are collected for evaluation. Participants are followed for one month after the consultation to monitor adverse events, including hospitalizations. Data collected include the proportion of prescriptions containing PIMs, average number of PIMs per prescription, deprescribing rates, and potential adverse drug reactions or interactions. Researchers assess the impact of the tool on improving prescription quality and reducing medication-related risks, with the total participation lasting from enrollment through follow-up.

This research aims to evaluate a culturally tailored mobile interactive education and support group intervention called MeSSSSage among postpartum Indian women. The study focuses on improving health-related knowledge, behaviors, and outcomes for mothers and newborns, addressing challenges like limited postpartum care access and social isolation. It is a randomized controlled trial involving 2100 women from three diverse Indian states, intending to assess the interventions impact, mechanisms, and cost-effectiveness. Participants in the intervention group receive 26 education and support sessions over eight months, including two prenatal and weekly postpartum sessions up to six months after birth. The sessions are delivered via audioconference and moderated by community health workers, with additional engagement through a provider-moderated group text chat. The control group receives standard postnatal care. The intervention is designed to supplement usual care and overcome barriers through mobile technology and social support. During the study, participants will be assessed on exclusive breastfeeding, postpartum depression, and family planning adoption at six months. Other outcomes include knowledge of maternal and neonatal danger signs, healthcare use, and infant vaccination. Researchers will monitor participant engagement and analyze how the intervention influences knowledge, social support, self-efficacy, and behaviors. The study also includes cost-effectiveness analyses and will follow participants for eight months to gather comprehensive data on postpartum health and well-being.