Active clinical trials for "Psychotic Disorders"

Lyndra Therapeutics, Inc. is developing LYN-005, a long-acting oral (LAO) capsule (LYNX™ dosage form) of risperidone. This pivotal study (LYN-005-C-301) will evaluate the PK as well as safety and tolerability of multiple administrations of the LYN-005 formulation at two dose levels.

Psychotic disorders are associated with high levels of distress, limitations in quality of life, and a high risk of chronification for those affected. The treatment guidelines recommend combining the pharmacological treatment with psychotherapeutic methods, starting already in the acute phase. At the same time, there is little research evidence on which mechanisms of psychotherapy are most effective and best feasible for the acute setting. Therefore, we want to run a pilot study to test specific psychotherapeutic interventions for patients with psychosis on acute psychiatric wards. The method of "Motivational Interviewing" is a well-known and established interviewing technique, which originally comes from the treatment of addictive disorders. In our study, it is used to strengthen the therapeutic alliance between patient and practitioner already in the acute phase of the disease, to increase adherence, and thus to achieve the overall goal of better integrating patients with pronounced positive symptoms into treatment. This appears to be extremely important, as non-adherence represents one of the greatest risks for chronification of the disease. The intervention will subsequently be evaluated in comparison to "treatment as usual".

This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.

Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.

This is an open-label, sequential cohorts, flexible dose study to evaluate the tolerability, safety and pharmacokinetics of iloperidone in elderly patients with Parkinson's disease psychosis (PDP).

Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.

A focus of research for youth and Emerging Adults with early phase psychosis (EPP) has been cannabis use. However, this focus has led to overlooking the possible negative influence of another legal recreational drug, alcohol. Previous studies our research group has done have demonstrated that over use of alcohol reduces the effectiveness of early intervention in psychosis treatment services. These treatment services are wrap around services that address medical, and social needs of young people with psychosis. Individuals with alcohol use disorder and EPP have fewer positive symptoms such as hallucinations which are the aspects of psychotic disorders that respond most readily to medication but have greater levels of depressive symptoms. Biologically, we can see the negative impact of alcohol on brain structure in our MRI studies. Our aim presented in this grant is to pilot a psychosocial intervention using cognitive enhancement therapy to reduce alcohol consumption in individuals with early phase psychosis. This intervention has shown promise in reducing alcohol use in individuals with long standing schizophrenia and compare it to treatment as usual which involves brief (1 session) psychoeducation. The investigators hope to reduce substance use in young people in the early stages of a psychotic disorder and improve their odds of a full recovery. In addition to measuring symptoms and hospitalizations, this trial will measure what are called social determinants of health such as return to school or work and resumption of relationships. These variables have not been measured previously in alcohol use interventions in this population but in our experience are the best indicators of long term recovery from psychosis. The symptoms will generally improve with antipsychotic drug treatment but reach a threshold after 6 months in most individuals who engage with our 5 year program. Further functional and social recovery seem to be the best determinants of a full return to health in this population.

Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher mortality. The prevalence of psychosis increases rapidly from age 14 onwards with a peak incidence in the late teens and early 20s. The aim of the project is to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare-PK', for individuals with psychosis in Pakistan. The main objectives are to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.

An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.

Psychosis is a highly distressing mental health condition, affecting up to 3% of the population. Conceptually, it has much in common with complex post-traumatic stress disorder (CPTSD), a recently introduced condition in ICD-11. Both involve negative self-esteem, impaired emotion regulation ability, interpersonal difficulties and intrusive trauma- related experiences (i.e. intrusive thoughts, flashbacks, nightmares). Both have been causally related to childhood trauma, such as abuse, neglect and loss. The current project will examine the feasibility of conducting an 'Umbrella trial' to test whether CPTSD is causally related to psychosis, and develop more effective trauma-focused psychological interventions for psychotic symptoms by treating underlying experiences of/reactions to trauma. An Umbrella trial involves running several individual randomised controlled trials concurrently. In this study, each trial will test whether psychological interventions designed to reduce different CPTSD symptoms cause improvements in psychotic symptoms. If the investigators can establish feasibility of this Umbrella trial, and if a definitive version shows that interventions for CPTSD also reduce psychosis, then this would be a breakthrough in both the conceptualisation and treatment of psychosis which will help transform the care of people with psychosis. Demonstrating the feasibility of our proposed methodology would also help to accelerate the development of interventions for other mental health problems.