Ongoing Clinical Trials for Psychotic Disorder
There are currently 13 ongoing clinical trials investigating various treatments for psychotic disorders, including psychosis associated with Alzheimer’s disease, schizophrenia, first episode psychosis, and substance-induced psychosis. These studies are taking place across multiple countries in Europe, testing medications such as KarXT, cannabidiol, rituximab, and memantine, as well as examining personalized dosing strategies and the effects of reducing antipsychotic medications.
Clinical trial locations
- Belgium
- Bulgaria
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Croatia
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Czechia
- Denmark
- France
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Study on Reducing Antipsychotic Dose vs. Maintenance Treatment for Patients with Schizophrenia Using Haloperidol Decanoate, Risperidone, and Amisulpride
- Study on the Effectiveness of Calcium Folinate, Omega-3-Acid Ethyl Esters, and Cyanocobalamin for Patients at High Risk of Psychosis or Experiencing First Episode Psychosis
- Germany
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on Improving Social Skills in Schizophrenia Using Oxytocin or Placebo as an Add-On Treatment for Patients with Schizophrenia Spectrum Disorders
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Study on Personalized Dosing of Sertraline, Aripiprazole, and Risperidone for Patients with Mood, Anxiety, or Psychotic Disorders
- Greece
- Hungary
- Italy
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Study on Cannabidiol and Aripiprazole for Treating Substance-Induced Psychosis in Young Patients
- Netherlands
- Poland
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Portugal
- Romania
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Slovakia
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Spain
- Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
- Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
- Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
- Study on Personalized Dosing of Sertraline, Aripiprazole, and Risperidone for Patients with Mood, Anxiety, or Psychotic Disorders
- Study on the Effectiveness of Aripiprazole and Paliperidone in Patients Experiencing Their First Episode of Schizophrenia
- Sweden
Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease
This study focuses on treating psychotic symptoms in people with Alzheimer’s disease using a medication called KarXT, which combines two active substances: trospium chloride and xanomeline tartrate. The medication is taken as capsules by mouth over several weeks.
Who can participate: Adults between 55 and 90 years old with confirmed Alzheimer’s disease who have experienced hallucinations or delusions for at least 2 months. Participants must have had a brain scan within the past 5 years to rule out other conditions. Both men and women can join the study.
Who cannot participate: People with a history of other psychotic disorders unrelated to Alzheimer’s, those currently using antipsychotic medications, individuals with severe medical conditions, heart problems, recent seizures, active substance abuse, severe kidney or liver problems, or those unable to provide consent.
What the study examines: The trial tests whether KarXT can reduce hallucinations and delusions in Alzheimer’s patients. Researchers will assess changes in symptoms using standardized tools and monitor overall health throughout the treatment period. The study compares KarXT with a placebo to determine its effectiveness.
Medications being tested: KarXT is an investigational treatment designed to reduce psychiatric symptoms without the common side effects of current antipsychotic medications. The trial also includes a placebo for comparison purposes.
Study on Improving Social Skills in Schizophrenia Using Oxytocin or Placebo as an Add-On Treatment for Patients with Schizophrenia Spectrum Disorders
This trial examines whether oxytocin, a naturally occurring hormone given as a nasal spray, can improve social skills when added to standard psychosocial treatment for people with schizophrenia spectrum disorders. The study lasts 12 weeks.
Who can participate: Adults aged 18 to 64 with schizophrenia or other primary psychotic disorders who have at least one moderate negative symptom and are receiving psychosocial treatment at least twice weekly. Women who can become pregnant must use reliable birth control methods.
Who cannot participate: People without a diagnosis of schizophrenia or primary psychotic disorders, those outside the age range, individuals not receiving psychosocial treatment, and members of vulnerable populations.
What the study examines: The trial evaluates whether adding oxytocin to regular psychosocial treatment can enhance social skills and overall functioning. Researchers will monitor changes in personal and social performance, quality of life, and cognitive function throughout the 12-week period.
Medications being tested: Oxytocin nasal spray is tested as an add-on treatment to determine if it can enhance the effectiveness of standard psychosocial care in improving social interactions.
Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
This trial investigates ITI-1284, a sublingual tablet medication, for treating psychotic symptoms in individuals with Alzheimer’s disease. The study compares the medication with a placebo over six weeks.
Who can participate: Patients aged 55 or older with a body mass index between 18 and 40 who have confirmed Alzheimer’s disease with associated psychotic symptoms lasting at least one month. Participants must score appropriately on specific assessment scales and live at home or in a care facility with caregiver support.
Who cannot participate: Individuals with psychosis unrelated to Alzheimer’s, those outside the age range, people unable to give consent, those with serious interfering medical conditions, and individuals currently in another clinical trial.
What the study examines: The trial assesses whether ITI-1284 can reduce psychotic symptoms and improve quality of life in Alzheimer’s patients. Weekly assessments track changes in symptoms using standardized scales over the six-week treatment period.
Medications being tested: ITI-1284 is an investigational medication taken once daily, designed to help manage hallucinations and delusions in people with Alzheimer’s disease.
Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis
This extended study evaluates the long-term safety and tolerability of KarXT over up to 52 weeks in patients with Alzheimer’s-related psychosis who completed previous KarXT trials.
Who can participate: Individuals aged 55 to 90 who completed study KAR-031 or KAR-032, can move around independently or with assistance, and have a caregiver who spends about 10 hours weekly with them. Women of childbearing age must use reliable birth control.
Who cannot participate: People without Alzheimer’s-related psychosis, those outside the specified age range, individuals not part of the previous trial groups, and those unable to meet study requirements.
What the study examines: The trial monitors long-term side effects and tolerability of KarXT. Regular visits assess medication compliance, symptom changes, and overall health over the extended treatment period.
Medications being tested: KarXT capsules containing trospium chloride and xanomeline tartrate are examined for long-term safety in managing psychotic symptoms associated with Alzheimer’s disease.
Study of Cannabidiol and Risperidone for Treatment of Non-Affective Psychosis in Patients with History of Cannabis Use
This seven-week trial examines whether cannabidiol (CBD) is effective in treating psychotic symptoms in people with various psychotic disorders who have used cannabis. Participants receive either CBD, risperidone, or placebo.
Who can participate: Adults aged 18 to 45 with diagnoses such as schizophrenia, paranoid psychosis, acute psychotic disorder, schizoaffective psychosis, or cannabis-induced psychotic disorder, who have specific symptom severity levels and have used cannabis at least once. Women of childbearing age must use effective birth control.
Who cannot participate: Individuals with current substance use disorder, severe liver disease, serious adverse reactions to CBD, cardiovascular disease, unstable medical conditions, pregnant or breastfeeding women, those unable to provide consent, and people with severe kidney dysfunction.
What the study examines: The trial evaluates CBD’s effectiveness in reducing psychotic symptoms, monitors cannabis use patterns, assesses sleep quality, mental function, and overall well-being throughout the seven-week period.
Medications being tested: Cannabidiol oral solution and risperidone tablets are tested, along with matching placebos, to determine their effectiveness in treating psychosis in people with a history of cannabis use.
Study of Rituximab for Patients with Psychosis or Obsessive-Compulsive Disorder Linked to Immune System Involvement
This trial investigates rituximab, a medication targeting the immune system, for treating patients with psychosis or obsessive-compulsive disorder where immune involvement is suspected. The study compares rituximab with placebo.
Who can participate: Adults aged 18 to 55 with diagnoses of OCD, obsessive-compulsive behavior, or psychotic disorders showing signs of active inflammation, with disease onset within 10 years. Participants must have moderate or greater illness severity, speak Swedish or English, and have tried at least two standard medications without success.
Who cannot participate: People with severe allergic reactions to medications, active infections requiring treatment, current use of immune-affecting drugs, recent cancer history, pregnant or breastfeeding women, severe heart disease, uncontrolled high blood pressure, severe liver or kidney disease, recent participation in other trials, and those with recent substance abuse.
What the study examines: The trial assesses whether rituximab can improve psychiatric and neurological symptoms in patients where immune system involvement is suspected. Regular evaluations over several months track symptom changes and overall health.
Medications being tested: Rituximab, administered through intravenous infusion, is examined for its potential to help patients with psychosis or OCD when immune system involvement is indicated.
Study on Continuing or Reducing Antipsychotic Medication (Haloperidol, Clozapine, Tiapride) for Patients After First Episode of Psychosis
The HAMLETT study examines whether patients who have recovered from their first episode of psychosis should continue their current antipsychotic medication or gradually reduce or stop it. The study lasts up to 24 months.
Who can participate: Individuals aged 16 to 60 with a first episode of psychosis who have been in remission for 3 to 6 months, are currently taking antipsychotic medication, understand the study, and speak Dutch.
Who cannot participate: People who have not experienced a first episode, are not in remission, cannot follow study guidelines, have interfering medical conditions, are pregnant or planning pregnancy, are in another trial, have severe allergic reactions to study medications, or cannot provide informed consent.
What the study examines: The trial compares continuing medication versus reducing or stopping it, monitoring personal and social functioning, side effects, quality of life, and overall health over both short-term and long-term periods.
Medications being tested: Various antipsychotic medications including haloperidol, clozapine, tiapride, and others are examined to determine the best approach for maintaining remission after a first episode.
Study on Personalized Dosing of Sertraline, Aripiprazole, and Risperidone for Patients with Mood, Anxiety, or Psychotic Disorders
This 24-week trial compares personalized medication dosing based on genetic makeup with standard dosing methods for people with major depressive disorder, bipolar disorder, anxiety disorders, or psychotic disorders.
Who can participate: Adults aged 18 to 64 with moderately severe depressive episodes, anxiety disorders, or psychotic disorders who have not responded adequately to at least one previous treatment and are about to switch medications. Participants must provide written consent and agree to allow use of medical information. Women of childbearing age must have negative pregnancy tests and use effective birth control.
Who cannot participate: The specific exclusion criteria for this study are not detailed in the provided information.
What the study examines: The trial evaluates whether tailoring medication doses based on pharmacogenetics leads to better recovery, well-being, quality of life, and fewer side effects compared to standard dosing practices.
Medications being tested: Sertraline, escitalopram, aripiprazole, and risperidone are tested using either pharmacogenetics-based personalized dosing or standard dosing approaches.
Study on Reducing Antipsychotic Dose vs. Maintenance Treatment for Patients with Schizophrenia Using Haloperidol Decanoate, Risperidone, and Amisulpride
This trial compares reducing antipsychotic medication doses versus maintaining current treatment for patients with schizophrenia spectrum disorders who have been clinically stable for at least six months. The study lasts up to 24 months.
Who can participate: Adults aged 18 to 60 who are clinically stable for at least 6 months, being treated with oral antipsychotic medications, have a Personal and Social Performance score greater than 70, are covered by health insurance, and have a diagnosis of schizophrenia spectrum disorder including schizophrenia, schizophreniform, schizoaffective disorder, or brief psychotic episode. Participants must be outpatients followed by a psychiatrist and have an identified caregiver.
Who cannot participate: Individuals without schizophrenia spectrum disorder diagnoses, those outside the age range, or those not meeting the specified clinical criteria.
What the study examines: The trial determines whether dose reduction or maintenance treatment is more effective based on the type of psychotic symptoms experienced. Regular assessments monitor daily functioning, side effects, well-being, and quality of life.
Medications being tested: Various antipsychotic medications including haloperidol decanoate, risperidone, amisulpride, and others are examined to determine optimal dosing strategies for stable patients.
Study on the Effectiveness of Aripiprazole and Paliperidone in Patients Experiencing Their First Episode of Schizophrenia
This trial compares two medications, Aripiprazole (Abilify Maintena) and Paliperidone (Xeplion), given as long-acting injections for treating first episode schizophrenia. The study lasts up to one year.
Who can participate: Individuals aged 15 to 40 living in the study area who are experiencing their first psychotic episode with a diagnosis within the schizophrenia spectrum, including schizophreniform disorder, schizophrenia, schizoaffective disorder, brief psychotic disorder, or psychotic disorder not otherwise specified.
Who cannot participate: People who have not experienced a first psychotic episode, do not have schizophrenia or treatment-resistant schizophrenia, are outside the age range, are unwilling or unable to follow study procedures, or are part of vulnerable populations.
What the study examines: The trial uses advanced techniques to identify biological markers predicting treatment response. Researchers monitor symptom changes, side effects, and treatment continuation at three and twelve months.
Medications being tested: Aripiprazole and paliperidone, administered as prolonged-release injections, are compared to determine which is more effective for patients experiencing their first psychotic episode.
Additional trials are also being conducted in France, Italy, and Denmark, examining personalized care approaches, cannabidiol for substance-induced psychosis, and memantine for reducing negative symptoms in first episode psychosis. These studies reflect ongoing efforts to improve treatment options and outcomes for individuals with various psychotic disorders.
Summary
The 13 ongoing clinical trials for psychotic disorders span multiple European countries, with notable concentrations in Spain, Germany, France, Romania, Slovakia, Bulgaria, and Italy. Several countries host multiple studies, particularly those investigating KarXT for Alzheimer’s-related psychosis.
A significant focus across trials is on psychosis associated with Alzheimer’s disease, with three separate studies examining KarXT’s short-term effectiveness, long-term safety, and an alternative medication called ITI-1284. This concentration suggests growing interest in addressing psychiatric symptoms in neurodegenerative conditions.
Another prominent theme is first episode psychosis, with trials examining various approaches including medication comparison studies, dose reduction strategies, and add-on treatments. Studies are investigating whether to maintain or reduce antipsychotic medications after initial stabilization, reflecting questions about long-term treatment strategies.
Several trials explore novel or repurposed medications, including oxytocin for social skills improvement, rituximab for immune-mediated psychosis, cannabidiol for cannabis-related psychosis, and memantine for negative symptoms. These studies represent efforts to address symptoms not adequately managed by traditional antipsychotics.
Personalized medicine approaches appear in multiple trials, with studies examining pharmacogenetics-based dosing and composite personalized care combining biological testing with digital cognitive reinforcement tools.
The trials collectively address diverse patient populations, from adolescents to older adults, and various manifestations of psychotic disorders, suggesting a comprehensive approach to understanding and treating these complex conditions across the lifespan and different clinical presentations.
