Active clinical trials for "Psychotic Disorders"

Schizophrenia is a serious mental disorder with a heterogenous presentation, lack of clear understanding of pathophysiology and only partially effective treatments. First-line antipsychotic drugs block dopamine, but many people continue to suffer from persistent positive or negative symptoms that cannot be fully treated with available medications. Recently, our group has found that dietary modulations have efficacy comparable to antipsychotic medications and that determining which patients could benefit from a personalized treatment framework is critical. The ketogenic diet consists of low-carbohydrate, moderate protein and high fat intake inducing a state in which ketone bodies in the blood provide energy to the cells. In pharmacologic mouse models a ketogenic diet regimen resulted in complete restoration of normal behaviors, independent of strict caloric restriction and other work has suggested that a ketogenic diet may improve schizophrenia like deficits in rodents. An open label ketogenic diet study in the 1950s reported improvement in schizophrenia symptom. At least 7 additional case reports have found robust improvements or complete resolution of schizophrenia symptoms. Recently a retrospective study found robust and significant improvements in schizophrenia symptoms in 10 schizoaffective disorder patients treated with a ketogenic diet. In addition to psychiatric symptoms, improvements in metabolic outcomes have been demonstrated. However, to date, there have been no published double blind randomized controlled trials evaluating the effects of a ketogenic diet since few sites can conduct inpatient trials and have observation and control for food intake

Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.

Sleep problems are pervasive in people with schizophrenia. In our study, our goal is to determine whether we can alleviate sleep symptoms and improve quality of life and well-being in patients with major psychiatric disorders through cognitive behavioral therapy (CBT) delivered via the internet or in groups. At the same time, the study provides information on factors that are commonly associated with sleep and well-being in patients. The intervention study is conducted as a Randomized Controlled Clinical Trial (RCT), in which subjects are randomized into three groups: 1) Treatment as usual (TAU), 2) TAU and Internet-based therapy for insomnia (ICBT-I), and 3) TAU and group therapy for insomnia (GCBT-I).

The proposed study is a 3-site, 12-week, novel, feasibility, investigation of patients who have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol, cocaine, heroin, or cannabis). Eighty patients will be randomly assigned to switch to brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the control group). The study will be conducted at 3 sites in the US. The investigators expect to enroll 80 subjects across 3 sites. UMass Medical School, Worcester MA is the lead site. Sub-sites include Massachusetts General Hospital (MGH) and the University of North Carolina at Chapel Hill (UNC).

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

A rater-blinded randomized controlled trial with a parallel-group design is utilized, comprised of yoga-based group therapy (YBGT) in the experimental condition, and treatment as usual (TAU) in the control condition. The participants in the experimental condition participate in YBGT beside their regular psychiatric treatment (TAU). The intervention is designed for in-patients with schizophrenia spectrum disorders. With the aim of examining the feasibility, acceptability and effectiveness, self-report and blinded rater-based assessments are evaluated before the YBGT (T0), and after four weeks of taking part in intervention (T1).

This study is to examine the effect of Acceptance and Commitment Therapy applied to patients in early psychosis patients on psychotic symptoms and functionality levels.

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

The study is a feasibility study of a combined high intensity aerobic and strenght exercise program for persons with psychotic disorders. The feasibility of the protocol will be investigated, in addition to the participants subjective experience with the participation.

Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.