Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Anti-PsychoticManagement of Manifestations of Psychotic Disorders7 moreCycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD. The aim of this pilot study is to investigate intrasubject variability in the bioavailability of Chlorpromazine Hydrochloride 25 mg sugar coated tablets. Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve and a wide safety margin. This will then allow for the modification of bioequivalence acceptance criteria in future pivotal studies which will reduce the number of participants required whilst still maintaining assurance of safety and efficacy. Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine; 7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%
Mental Health Intervention for Transdiagnostic Groups in the Community
Severe Mental IllnessThe investigators propose to evaluate a new protocol-based intervention that is informed by Dialectical Behaviour Therapy (DBT), known as a DBT-informed intervention, delivered in routine mental health settings within South London and Maudsley NHS foundation trust. The intervention is delivered to a group of transdiagnostic service users with a severe mental illness (SMI). It is delivered by a junior workforce who will be referred to as Protocol-Based Intervention Facilitators (P-BIFs). Successful delivery by a less expert workforce has potential to increase routine implementation, compared to delivery by expert staff, where costs of both salary and training are higher. Dialectical Behaviour Therapy (DBT) is a type of psychological treatment recommended for people with a diagnosis of emotionally unstable personality disorder (EUPD). Individuals with a diagnosis of EUPD commonly experience difficulties with managing and responding to their emotions. This is known as emotion dysregulation. Difficulties with emotion dysregulation are thought to play a role in many mental health difficulties. The evidence base for using interventions that are informed by DBT, known of as DBT informed interventions with other mental health diagnoses, is emerging. The current research aims to investigate whether it is possible (feasible) to conduct a randomised control trial evaluating the transdiagnostic DBT-informed skills group for individuals representative of SMI presentations seen within community mental health settings. The study will also examine whether it is possible for junior staff to deliver the manualised group intervention. Service user participants will be randomised to either a 10-week DBT-informed intervention delivered by the P-BIFs, or a waitlist. Those on the waitlist will access the intervention once their involvement in the study has ended. The study will last for up to 1 year. The maximum duration to complete trial participation from consent to completion will be 18 weeks. It is hypothesized that the DBT informed intervention, delivered by junior staff, will be feasible and acceptable with this client population.
Needs Tailored Recovery Program for Patients With Severe Mental Illness
Mental IllnessSchizophrenia1 moreThe purpose of this study is to establish an innovative smart e-care needs tailored recovery program (NTRP) platform for the community-dwelling patients with severe mental illness, and then evaluate the effectness of e-care needs tailored recovery program (NTRP).
HCT Effect Among Patients With Psychotic Disorders
Psychotic DisordersHorticulture therapy has been found to have positive effects on individuals with psychotic disorders, promoting social interaction, reducing social isolation, and improving cognitive function. Effectiveness of horticulture therapy in enhancing well-being, reducing symptoms, and facilitating social adjustment in this population
Arena Labs - Improving Clinician Well Being
Mental Health DisorderTo determine the efficacy of the asynchronous performance coaching platform, Arena Strive at changing measures of physiological resilience, professional fulfillment, burnout, and self-valuation in full time clinicians.
Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
Mental DisordersWe are conducting a randomized clinical trial (RCT) comparing the 10-week peer-led Photovoice program to services as usual (SAU) at a large publicly funded community mental health agency in Massachusetts. The control SAU condition will be enhanced with a 60-minute peer-led group educational session about understanding and coping with prejudice and discrimination. The 10-session, peer-led Photovoice program, designed to empower individuals with serious mental illness (SMI) to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness. Development of the Photovoice program was guided by an adaptation of the stress-coping model, informed by recent research and conceptualizations of the effects of stigma on people with SMI. The stress-coping model explicates the mechanisms by which public stigma about mental illness can lead to personal stigma, which in turn has a negative impact on the person's mental health and psychosocial functioning. This model also identifies critical factors that contribute to personal stigma or protect against it, as well as more vs. less adaptive coping responses, that are the primary focus of the Photovoice program.
Mental Health eConsults
Mental DisordersThe purpose of this study is to assess whether electronic consultations between primary care providers and psychiatrists affects mental health services delivered in primary care settings.
Impact of an Intensive Multimodal Educative Program on Behavioral Disorders of Patients With Profound...
PolyhandicapBehavior DisordersProfound multiple disabilities also called in French polyhandicap are defined by the combination of a deep mental disability and severe motor deficit with extreme restriction of autonomy. Life in institution for people with profound multiple disabilities induces emotional and educative deficiency and often conducts to behavioral disorders. These behavioral disorders also impact on quality of life and feelings of caregivers. An intensive multimodal educative program proposed to patients with profound multiple disabilities can improve their psychic well-being, reduce chronic pain and improve also quality of life and feelings of caregivers. The intensive multimodal educative program will be compared to the usual practice of educative program.
H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation
Developmental DelayMental Health DisorderThe goal of this project is to develop and pilot test a community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems that is replicable, effective, and sustainable. Project procedures include child mental health screening, on-site brief mental health interventions, referral to specialty mental health, use of co-located child psychiatrist, detection of need for primary care in specialty mental health program. Subjects will be enrolled for 1 year, with interviews at baseline and 3, 6 and 12 months. Dr. Bonnie Zima at UCLA has been contracted by the project funder to design and implement the evaluation of the project, which includes developing data collection procedures, training staff on implementation of data collection workflow, coordinating with sites to ensure evaluation design and IRB protocols are followed, and coordinating with both study sites to verify data reliability. Some potential anticipated risks include being uncomfortable answering questions associated with the measures used in the study, and although unlikely, someone may access participant information that is confidential. Some benefits include helping to find ways to improve how to deliver mental health care for children served in publicly-funded primary care and mental health clinics.
Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta,...
Mental DisordersThis study is a cluster randomised controlled trial, which aims to examine the short-term strategy of addressing treatment gap through increasing primary mental health service capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients.