Agitation

This research aims to evaluate a new brief and individually tailored behavioral parent training program designed for children aged 2 to 12 who experience behavioral difficulties such as oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behaviors. The study compares the short- and long-term effectiveness and cost-effectiveness of this brief parent training with optional booster sessions against the usual care provided by mental healthcare centers. The trial is conducted as a two-arm, multi-center randomized controlled trial embedded within routine mental healthcare settings. Parents in the intervention group receive a three-session training program two sessions of two hours each, delivered biweekly, followed by a one-hour session for evaluation and maintenance. Afterward, they may opt for additional booster sessions, each lasting one hour and offered up to once every four weeks for one year. The control group receives care as usual, which may include psychoeducation, parent counseling, long parent training, child therapy, or family therapy, with no restrictions on type or duration except exclusion of the brief program. Participants provide information on child behavior, well-being, parenting behaviors, and stress through questionnaires, audio recordings of mealtime routines, and daily phone calls at four timepoints baseline, shortly after the intervention or equivalent time for controls, six months later, and twelve months later. Researchers measure changes in specific behavioral difficulties parents aim to address, alongside secondary outcomes like child well-being and parenting stress. Therapists and parents evaluations of the program are also collected. The study monitors adherence and intervention fidelity through audiotaped sessions and supervision. Participation lasts up to one year with regular assessments.

Researchers are studying ways to improve teaching self-control and communication skills to children and adolescents aged 6 to 17 with challenging behaviors. The goal is to find methods that make behavior-change treatments more effective and long-lasting, even when environments or reinforcement schedules change. The study looks at how cognitive and behavioral factors like memory, timing, and decision-making affect treatment success. Participants will receive a behavioral intervention that includes functional communication training to teach appropriate communication responses, extinction-correlated stimuli to signal reinforcement changes, schedule thinning to reduce reinforcement frequency, competing stimuli to reduce challenging behaviors during delays, and caregiver training to support skill use at home. These approaches will be personalized and applied in structured sessions. During the study, participants will complete assessments to identify preferred activities and understand causes of challenging behaviors. They will learn new communication skills to replace problem behaviors and practice transferring these skills to new situations and people. Researchers will monitor changes in challenging behavior from enrollment through 16 weeks of intervention to evaluate treatment durability and generalization.

Researchers are evaluating ITI-1284, a drug being studied for agitation associated with Alzheimers dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients aged 55 years and older who experience agitation related to Alzheimers disease. The study is sponsored by Intra-Cellular Therapies, Inc. and follows strict clinical criteria for diagnosis and agitation severity. Participants are randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is given as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study consists of three periods a screening period lasting up to 4 weeks to assess eligibility, a 12-week double-blind treatment period where the assigned study drug is taken daily, and a 30-day safety follow-up period after the last dose to monitor any effects. During the study, participants will have assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation levels at Week 12. Other evaluations include the Clinical Global Impression-Severity CGI-S score and cognitive testing with the Mini-Mental State Examination. Safety monitoring occurs throughout the treatment and follow-up periods. Overall, participation lasts approximately 16 to 17 weeks, covering screening, treatment, and safety checks.

This research aims to evaluate the long-term efficacy and safety of a combined formulation of xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for treating agitation in participants with Alzheimers Disease. The study focuses on individuals who have completed prior parent studies CN012-0023 or CN012-0024 and seeks to understand treatment effects over an extended period. Participants will receive specified doses of KarXT and KarX-EC on designated days as part of this single-group, non-randomized study. The treatment phase lasts up to approximately 30 weeks, during which the combined drugs are administered and monitored for safety and effectiveness related to agitation management in Alzheimers Disease. Throughout the study, participants will be monitored for treatment-emergent adverse events and other safety measures. Assessments include tracking adverse events, serious adverse events, changes in vital signs, laboratory evaluations, electrocardiograms, cognitive function tests like the Mini-mental State Examination and ADAS-Cog-13, as well as symptom severity scales. Caregiver involvement is required to provide support and facilitate study participation. The total study duration extends up to about 30 weeks with ongoing safety and efficacy evaluations.

Researchers are evaluating treatments for acute agitation in psychiatric patients when de-escalation methods do not work. The study aims to find the best medication to reduce suffering and prevent harm or the use of restraints in emergency psychiatric settings. This research focuses on two less-studied drugs compared to the current standard care. The plan includes building a platform to test new treatments and improve care quality for agitated patients. The study tests three medication options sublingual dexmedetomidine, buccal midazolam, and oral lorazepam. Each drug may be given with a possible second dose two hours later. Participants are randomly assigned to one of these treatments without masking. The goal is to compare how well these drugs control agitation in hospital psychiatric settings. Participants will be monitored for agitation levels using the Excited Component of the Positive and Negative Syndrome Scale PEC at multiple times after dosing. Researchers will also track whether patients become calm or asleep, the use of physical or mechanical restraints, rescue medications, and patient satisfaction within 24 hours after treatment. The study runs until December 2027 and involves regular assessments during the inpatient stay to evaluate safety and treatment effects.

This research aims to prevent unnecessary deaths from cervical cancer in Senegal by addressing barriers to early screening, follow-up, and treatment among women. The study applies the Dynamic Adaptation Process within the Exploration, Preparation, Implementation, Sustainment EPIS framework to adapt an evidence-based cervical cancer patient navigation program in both urban and rural settings. It evaluates the programs effectiveness and implementation outcomes, focusing on how adaptations address stigma, misinformation, and womens autonomy in healthcare decisions. The study involves adapting the Chicago Chinatown Patient Navigation Program to fit the contexts of Kedougou and Dakar regions in Senegal. It uses a stepped-wedge randomized pragmatic trial across six districts, where clusters transition from standard care to the adapted navigation program. Patient navigators work with community health workers to help women overcome personal and community barriers to screening and follow-up care. The study also measures implementation factors such as feasibility, acceptability, fidelity, sustainability, and costs. Participants will complete surveys and medical record reviews at baseline and every 12 months for three years to assess screening uptake, time to treatment, stigma, decision-making autonomy, awareness, knowledge, and communication about cervical cancer. The research collects data from women and men involved in cervical cancer prevention services and evaluates the adapted programs success throughout exploration, preparation, implementation, and sustainment phases. The total study duration spans multiple years with repeated assessments to understand both health and community impacts.

Researchers are evaluating the effects and safety of different doses of intranasal midazolam to treat acute anxiety in adult palliative care patients. This double-blind, randomized, placebo-controlled exploratory pilot study aims to provide pharmacokinetic and pharmacodynamic data to better understand how midazolam works in this setting. The study enrolls hospitalized patients who are prescribed intranasal midazolam as needed and meet specific inclusion criteria. The study includes three groups a placebo group receiving no active midazolam, a group receiving 0.9 mg total dose, and a group receiving 1.8 mg total dose of midazolam through a nasal spray. Each participant receives one spray in each nostril. A nested analysis will examine pharmacokinetic parameters in patients with venous access by collecting blood samples at multiple time points up to 240 minutes after administration. Participants will be assessed before treatment and 30 minutes after for anxiety levels, sedation, oxygen saturation, heart rate, and cortisol in oral fluid. Additional measures such as time to first additional dose, cumulative doses over 24 hours, and adverse events will be tracked up to 24 hours post-treatment. Patients in the pharmacokinetic subgroup will have blood samples collected for detailed drug concentration analysis. The study plans to enroll 36 patients, with 12 in each group, and will monitor safety and response throughout the study period.

Researchers are investigating the changes in gene activity related to metabolic disorders in children and adolescents with neurodevelopmental disorders and irritability who are treated with antipsychotic drugs. The study aims to compare gene expression patterns in three groups those using antipsychotics with metabolic disorders, those using antipsychotics without metabolic disorders, and those with metabolic disorders not using antipsychotics. The goal is to identify early genetic markers that might predict the development of metabolic problems linked to antipsychotic treatment, which could help personalize therapy and reduce metabolic risks. Participants are divided into three groups based on their antipsychotic use and metabolic health status. The study involves a transcriptomic investigation, which examines gene activity from blood samples, followed by classification of these gene patterns. This observational study does not involve experimental treatment but focuses on understanding the biological changes associated with antipsychotic use and metabolic conditions. During the study, each participant will have their body mass index adjusted for age, sex, and height BMI-Z measured once at recruitment. Researchers will analyze gene expression in peripheral blood mononuclear cells to identify differences among the groups. The trial is led by IRCCS Eugenio Medea and includes children and adolescents aged 5 to 17 years. The study will continue until May 2026, with assessments focusing on metabolic and genetic markers relevant to antipsychotic treatment outcomes.

Researchers are studying how art therapy affects emotional expression and regulation in military service members with posttraumatic stress symptoms. The study aims to understand the neurological systems involved by using brain scans and self-assessment questionnaires. This research is conducted within the Military Health System where art therapy is a common treatment but lacks thorough scientific evaluation. Participants will attend a total of eleven sessions over six to eight months. The first session includes an interview, self-assessment questionnaires, and a brain MRI scan while viewing neutral and negative images. Then, participants take part in eight one-hour individual art therapy sessions with a certified art therapist. The tenth session repeats the questionnaires and MRI scan, and the final session is a virtual interview conducted three months after the tenth visit. Throughout the study, participants will complete various questionnaires measuring symptoms and traits related to posttraumatic stress, anxiety, stress, and emotional regulation. Brain activity during tasks will be assessed through functional neuroimaging. The research also monitors potential emotional distress during sessions and collects qualitative feedback. Overall participation lasts up to eight months with follow-up to evaluate lasting effects.

Researchers are evaluating how pharmacological and psychotherapeutic group treatments affect clinical symptoms in children and adolescents diagnosed with ADHD, emotional-behavioral dysregulation, and externalizing disorders. This observational study aims to determine the effectiveness of these treatments on symptoms and explore associations between individual characteristics and treatment responses using behavioral, neuropsychological, and neurophysiological data. The study seeks to develop more personalized interventions based on these findings. Participants will receive either pharmacological treatment with methylphenidate or group psychological therapy. The drug treatment involves a test dose followed by a varying daily dose 5-20 mg adjusted by a child neuropsychiatrist. The group psychological treatment includes 16 weekly sessions lasting 1.5 hours each over four months, divided into age-based groups. A control group of patients on a waiting list will undergo the same assessments but will not receive treatment. Participants will undergo assessments before treatment and at multiple follow-ups at treatment start, end of treatment or drug titration phase 2-3 months, and six months post-treatment. Assessments include clinical and socio-demographic questionnaires, computerized neuropsychological tests, and neurophysiological recordings using near-infrared spectroscopy, EEG during attention tasks, and data from a smartwatch. Researchers will analyze clinical symptoms, emotion regulation, neuropsychological performance, and neurophysiological measures to assess changes and predict treatment outcomes.