Clinical Trials for Psychotic Disorders

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Psychotic Disorders from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 24
• Active, not recruiting: 3
• Completed: 13
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04887792 — Acetazolamide for Treatment Resistant Schizophrenia

This is a double blind adjunctive randomized controlled trial for schizophrenia using acetazolamide.

NCT05340348 — Patientheque in Patients With a Psychosis

Establishment of a patient library for patients who have had a first psychotic episode and who have an “at risk” status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.

NCT05157620 — Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness

This is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioni…

NCT05980949 — Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer’s Disease (ADEPT-3)

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term…

NCT06229210 — Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

NCT07398365 — Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients

This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) “mental health” inpatient wards, providing the first detailed information on morbidity in this patient population.

NCT06674694 — The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.

Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.

NCT06345963 — Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.

NCT06633458 — Adolescent Psychiatry Inpatients: Self-reported Parent-adolescent Communication Quality and Treatment Outcome

The quality of parent-adolescent communication has been found to be associated with adolescent mental health. However, little is known about the association of parent-adolescent communication and adolescent mental health in the context of psychiatry inpatient treatment.

This study aims to find out whether self-reported parent-adolescent communication quality at the time of admission to psychia…

NCT06540833 — A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer’s Disease

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

NCT06585787 — A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer’s Disease (ADEPT-4)

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer’s Disease (AD) with moderate to severe psychosis related to AD.

NCT06894212 — A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

NCT06961916 — Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil combined with cognitive training for improving white matter integrity.

NCT06882785 — A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

NCT07093671 — Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)

The primary objective of this study is to evaluate the efficacy of Mentalization-Based Treatment (MBT) combined with Need-Based Clinical Interventions (NBCI) compared to NBCI alone, on CHR-P diagnostic statuses and symptom expression (Hypothesis 1). Specifically, the investigator will assess diagnostic outcomes using a 3-level variable: transition to psychosis, CHR-P status quo, and remission o…

NCT07671261 — SEEG-Guided DBS for Schizophrenia

This is a prospective, randomized, interventional study designed to evaluate the efficacy and safety of SEEG-guided deep brain stimulation (DBS) for symptom improvement in patients with treatment-resistant schizophrenia. Using stereo-electroencephalography (SEEG) to record brain activity, we will identify specific abnormal electrophysiological targets and signal features associated with clinica…

NCT07119268 — SPARK Healthy Sleep

SPARK-Healthy Sleep is a digital mental health intervention designed to help college students who may be at risk for psychosis and experience sleep problems. About 1 in 4 college students report psychotic-like experiences (such as hearing voices or feeling paranoid), and these students often have poor sleep quality, which can worsen their mental health symptoms.

This study tests whether a sing…

NCT07288567 — A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

NCT07410507 — A Study of Brenipatide in Adult Participants With Schizophrenia

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia.

The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months….

NCT07615426 — A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia

The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.

NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia

NCT06947941 — A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer’s Disease (ADEPT-5)

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer’s disease.

NCT07616999 — A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse

The study aims to address the following questions:

1. Do subgroups defined by early medication choices, relapse, and medication taken over 20 years differ in clinical, cognitive, and functional outcomes?
2. What are the long-term cognitive functioning trajectories, what factors predict these trajectories, and how do they relate to outcomes?
3. What might be the mechanisms behind medication dis…

NCT07682935 — Investigation of the Effects of Angling as Supportive Therapy in Schizophrenia Treatment on Serum Parameters, Anxiety, Depression, and Quality of Life

This study aims to evaluate the effects of recreational fishing (angling) as a supportive therapeutic intervention in individuals diagnosed with schizophrenia. Schizophrenia is a chronic psychiatric disorder characterized by disturbances in thinking, perception, emotion, and behavior, often accompanied by negative symptoms such as social withdrawal, anhedonia, and cognitive impairment, which si…

Active, Not Recruiting

NCT00001246 — Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers

Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to create a picture. MRI use as the name implies, magnetism to create pictures with excellent anatomical resolution. Functional MRIs are diagnostic tests that allow doctors to not only view anatomy, but physiology and function. It is for these reasons that MRIs are excellent methods for studying the brain.

In th…

NCT03781115 — Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia

Schizophrenia is a severe psychotic illness of unknown cause that affects 1% of the population worldwide. Currently, there is no diagnostic test for schizophrenia. Instead, the diagnosis is typically established through a psychiatric interview of the patient, who is evaluated against a set of established criteria of signs and symptoms. It can take many months to years to establish a diagnosis o…

NCT06304233 — The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease

To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.

Not Yet Recruiting

NCT07658898 — dACC-Targeted Temporal Interference for Negative and Cognitive Symptoms in Schizophrenia

This randomized, double-blind, sham-controlled trial aims to evaluate the efficacy and safety of dorsal anterior cingulate cortex-targeted temporal interference stimulation in individuals with schizophrenia. Participants will be randomly assigned to receive either active or sham stimulation for 10 sessions over two consecutive weeks. The primary outcome is the change in negative symptoms, asses…

NCT07680946 — Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia

The main objective of this Phase 2 study is to assess the efficacy of ublituximab as measured by positive and negative syndrome scale (PANSS) total score in participants with schizophrenia.

NCT07680114 — Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls

This study to find out whether a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity during sleep-especially sleep spindles (brain rhythms in the ~8-16 Hz range). The investigators are focusing on the thalamus, a deep brain region that helps coordinate brain activity during non-RE…

NCT07674914 — A Cognitive Mobile Intervention for Motivation in Psychotic Disorders

The goal of this study is to develop and test the impact of a smartphone-based working memory cognitive training digital therapeutic for individuals with schizophrenia or a related disorder.

NCT07686263 — Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

NCT06909422 — Mobile Thinking Intervention: A Inital Test

This study will test the inital efficacy of a brief mobile intervention targeting biased thinking.

NCT07620418 — CapExchange: A Pilot Feasibility Study of a Capacity-Exchange Programme for Mental Health Recovery

CapExchange is a psychosocial rehabilitation programme based on reciprocal exchange of capacities and services between service users and their community environment, grounded in the concepts of circular mutuality and micro-social contribution. This pilot feasibility study aims to assess the feasibility and acceptability of the programme within the Psychosocial Rehabilitation Service of the EPSM…

Enrolling by Invitation

NCT04007510 — California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis

The proposed project seeks to create a California early psychosis network using a core assessment battery of valid, low burden measures and mHealth technology platform to collect client-level data, visualize data via clinician dashboard for treatment planning, and integrate across clinics to provide de-identified data to the national coordinating hub. Research capacity for the network will be t…

NCT06194799 — ACP-204 in Adults With Alzheimer’s Disease Psychosis Open Label Extension Study

This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.

NCT07680959 — Combining HD-tDCS and iTBS in Treating Negative Symptoms of Schizophrenia

Dysfunction of the dorsolateral prefrontal cortex (DLPFC) is central to the persistence of negative symptoms in schizophrenia. Both HD-tDCS and iTBS targeting the left DLPFC have shown therapeutic benefit. This trial will test the hypothesis that combining HD-tDCS with iTBS yields additive efficacy.

Completed Trials

NCT00001258 — Studies of Frontal Lobe Brain Functioning in Schizophrenia

The purpose of this study is to use brain imaging technology to investigate the role of the frontal lobe of the brain in the thinking of individuals with schizophrenia and other neuropsychiatric disorders and healthy volunteers.

Participants in this study will undergo a positron emission tomography (PET) scan of the brain while performing neuropsychological tests. Some of the tests involve cog…

NCT00001486 — Genetic Study of Schizophrenia

This large ongoing study at NIMH investigates the neurobiology of schizophrenia by identifying susceptibility genes, evaluating their impact on brain function to better understand how to treat and prevent this illness.

NCT00942981 — Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography

Background:

• Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Medications that change brain dopamine receptors can decrease these hallucinations and delusions.
• The cause of schizophrenia and its association…

NCT05680727 — Individualized Functional Connectivity Targeting in aiTBS for Depression

The goal of this clinical trial is to estimate the importance of neuroimaging in accelerated intermittent theta burst stimulation (aiTBS) for depression. Participants will receive aiTBS treatment, but they will not know if their treatment spot was found with neuroimaging or head measurements.

NCT07359209 — Berberine Improving Cognitive Impairments in Schizophrenia

This study is a 12-week, randomized, blank-controlled, assessor-blinded trial. Eligible patients were randomized in a 1:1 ratio to receive either berberine hydrochloride or blank control as an add on to their stable antipsychotic regimen for 12 weeks. Randomization was performed using a computer-generated random number table, and allocation was concealed using sequentially numbered, opaque, sea…

NCT06253546 — Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia

Primary Objective:

To evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use in Chinese participants with schizophrenia.

Secondary Objectives:

• To evaluate the pharmacokinetics (PK) of single doses of TV-44749 administered sc.
• To evaluate the pharmacokinetics of oral olanzapine tablets following multiple dose administration.
• To monitor the safety and …

NCT06186570 — Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders

The proposed clinical trial aims to examine the efficacy of an online-based self-help intervention for auditory hallucinations in persons with psychotic disorders. The intervention is primarily based on Metacognitive Training (MKT) and Mindfulness-Based Group Therapy (MBGT). The investigators will utilize a mixed-method study design within a randomized controlled trial. The intervention group w…

NCT06627413 — Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.

NCT07671040 — A Pilot Study of Adjunctive Structured Supportive Psychotherapy in Schizophrenia

This pilot randomized controlled trial examined whether adding structured supportive psychotherapy to risperidone treatment is more effective than risperidone alone in improving cognitive function and reducing peripheral inflammation in stabilized inpatients with schizophrenia.

Forty-four male and female inpatients with schizophrenia were randomly assigned to two groups: the intervention group…

NCT07673718 — α-N-acetylgalactosaminidase in Schizoaffective Disorder

Schizoaffective disorder (SAD) is a severe psychiatric condition characterized by the coexistence of psychotic symptoms and mood episodes. Growing evidence suggests that immune dysregulation and inflammatory processes contribute to the pathophysiology of schizophrenia-spectrum disorders, including SAD. α-N-acetylgalactosaminidase is a lysosomal enzyme involved in glycoprotein metabolism and imm…

NCT07141966 — Assessment of Physical Activity, Balance, Muscle Strength, and Cognitive Function in Patients Diagnosed With Schizophrenia

Schizophrenia is a serious mental health condition that affects individuals’ thinking, perception, emotional responses, and behavior.

Balance in schizophrenia patients is often related to motor skills, coordination, and postural control.

Schizophrenia can cause functional changes in certain areas of the brain. These changes can affect motor functions.

Balance loss in schizophrenia patients c…

NCT07690098 — AgingUP: A Pilot Program to Reduce Self-Ageism and Self-Stigma in Older Adults With Severe Mental Illness

The goal of this pilot clinical trial is to learn whether AgingUP, a 10-session psychosocial program, helps reduce self-ageism and self-stigma and fosters more positive and realistic views of aging in older adults (≥50 years) living with severe mental illness.

The main questions it aims to answer are:

• Does participation in AgingUP reduce self-directed ageism compared to usual care?
• Does i…

NCT07364825 — Acute Psychiatric Care at Home for Lower-risk Patients With Acute Psychiatric Illness Who Require Inpatient Care

The goal of this pilot randomized controlled trial is to learn if adult patients with acute psychiatric conditions can receive hospital-level care at home. The main question it aims to answer is:

1. Estimate the eligibility rate for BHH among screened patients. What percentage of eligible patients agree to enroll in behavioral health home hospital (intervention)?