Bhopal

Researchers are evaluating the effectiveness and safety of brenipatide when given along with standard care compared to a placebo with standard care in adults with bipolar disorder. This Phase 2 study aims to see if brenipatide can delay the worsening of bipolar symptoms. The trial includes participants aged 18 to 75 years and involves a careful assessment of how well the treatment works and its safety profile. The trial has three main periods: a screening period lasting about one month, a treatment period of at least six months, and a follow-up period of around two months. Participants receive either brenipatide or placebo, both given by subcutaneous injection, alongside their usual bipolar disorder medications. The study may end earlier if symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study medication, maintain diaries, complete questionnaires, and attend regular visits throughout the study. Researchers will monitor the time to relapse, defined as the number of days from randomization until symptoms worsen according to specific criteria, over at least six months. Safety and adherence to treatment will also be closely observed during the study.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating a character-strengths based coaching intervention to reduce work-related stress and improve mental wellbeing among Accredited Social Health Activists (ASHAs), who are rural community health workers in the Sehore district of Madhya Pradesh, India. This trial aims to compare the coaching intervention to routine weekly supervision to see if it enhances ASHAs' self-reported wellbeing, burnout, motivation, and work performance. The study includes 330 female ASHAs and addresses the high stress they face due to both professional and domestic challenges in a low-resource rural setting. The intervention includes a five-day residential workshop teaching character-strength strategies to manage work stress, followed by 8 to 10 weeks of weekly remote telephonic coaching support to help ASHAs apply these strategies in their daily work. The control group receives the usual weekly face-to-face group supervision by supervisors. The coaching materials were carefully developed and tested for feasibility and acceptability. The study evaluates whether this combined workshop and coaching approach can be an effective and scalable way to support rural health workers. Participants will be assessed at baseline, 1-month, 3-month, and 6-month follow-ups by blinded assessors. Outcomes include scores on the Authentic Happiness Inventory to measure wellbeing, as well as assessments of affect, self-efficacy, flourishing, burnout, and motivation. Researchers will also explore service delivery indicators, patient satisfaction, and depression severity related to ASHA care. Costs of the intervention and any participant-incurred costs will be analyzed. ASHAs' self-perceived character strengths will also be measured at baseline and 3 months.

Researchers are evaluating whether a new deprescribing tool can reduce the use of potentially inappropriate medications (PIMs) among elderly patients in India. The study focuses on improving prescription quality and minimizing risks linked to polypharmacy, such as adverse effects, drug interactions, and high treatment costs. This tool is designed specifically for the Indian context, considering common medication practices like fixed dose combinations and use of medicines from different systems that are typical in India. Prescribers (physicians) are randomly assigned to either the control group, where they provide routine care without the tool, or the intervention group, where they use the deprescribing tool during consultations with elderly patients aged 60 years or older. The tool guides prescribers to review medications and decide if deprescribing is needed, which may include stopping a drug immediately, tapering off a medication gradually, or reducing the dose. Only one to three medicines are deprescribed at a time to monitor effects clearly. Participants' prescriptions are photographed after their consultations to compare the proportion of prescriptions containing PIMs between the two groups. Patients are followed up one month later by phone or during a routine visit to check for any adverse events, including hospitalizations. The study also collects feedback from prescribers to understand challenges and supports for using the tool. The main outcome measured is the change in prescriptions with at least one PIM from enrollment to the end of consultation, aiming to improve elderly medication safety in India.

Researchers are evaluating ways to improve treatment outcomes for adults with moderate to severe depression in primary care settings in India. This Phase 3 study aims to compare two treatments: a behavioral psychotherapy called the Healthy Activity Program (HAP) and antidepressant medication (fluoxetine). The study also seeks to develop a precision treatment rule using patients' baseline clinical, socio-economic, and cognitive characteristics to predict which treatment works best for each individual, and to identify patients who may need specialist care. Additionally, the study will assess the cost-effectiveness of allocating patients to their optimal treatment based on this precision rule. Participants will be randomly assigned to receive either HAP, which involves 6-8 sessions delivered by non-specialist healthcare workers focusing on behavioral activation and problem-solving, or fluoxetine starting at 20 mg daily with possible dose increases to 40 mg at weeks 3 or 6 if symptoms persist. Patients who cannot tolerate fluoxetine may switch to escitalopram. The study will compare outcomes between those who receive their predicted optimal treatment and those who do not. During the study, participants will be assessed for depression remission three months after recruitment using standardized questionnaires. Researchers will collect data on treatment adherence, costs, and clinical responses. The study also includes exploratory aims to understand treatment mechanisms and evaluate genetic predictors of response. Total participation includes follow-up through the remission assessment period, with safety and data quality monitored throughout.

Researchers are evaluating a culturally-tailored mobile interactive education and support group program called MeSSSSage to improve postpartum health among 2100 Indian women living in three diverse states. The study aims to see how the program affects knowledge, behaviors, and health outcomes related to mothers and newborns, especially focusing on exclusive breastfeeding, postpartum depression, and family planning. The trial also explores how social support, self-confidence, and behavior changes contribute to the program's impact and examines its cost-effectiveness compared to usual care. The intervention includes 26 group sessions delivered via audioconference by community health workers, starting in late pregnancy and continuing weekly through six months postpartum. Women participate in provider-moderated discussions and text chats designed to supplement standard postpartum care and overcome barriers like limited mobility and social isolation. The program uses mobile phones to connect participants with providers and peers, aiming to improve access and support in peri-urban and rural areas. Participants are followed for eight months, during which their health behaviors and outcomes are monitored. Researchers assess exclusive breastfeeding rates, postpartum depression, and use of family planning at six months. They also collect data on knowledge, social support, and self-efficacy to understand how the intervention works. Cost analyses will determine the value and efficiency of the program. The study's findings will help guide future efforts to scale up postpartum care interventions in similar settings.