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Clinical Trials for Schizophrenia: Current Research and Treatment Studies

This article provides information about 30 ongoing clinical trials investigating new treatments and approaches for schizophrenia. These studies explore medications, brain imaging techniques, and combination therapies aimed at improving symptoms, cognitive function, and quality of life for people with this condition. (Also known as: Psychotic Disorder, Psychosis)

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Study on Biomarkers for Predicting Response to Clozapine in Patients with Schizophrenia

This trial investigates the use of clozapine in patients diagnosed with schizophrenia or related conditions. The main focus is on identifying biological markers that might help predict how well patients will respond to this medication.

Inclusion criteria: Patients must be between 18 and 64 years old, have a confirmed diagnosis of schizophrenia or similar conditions, and have been on stable antipsychotic treatment for at least one month. They must have tried at least two different antipsychotic medications without sufficient improvement. Women of childbearing potential must use reliable contraception.

Exclusion criteria: Individuals without a diagnosis of schizophrenia, those outside the specified age range, or those considered part of a vulnerable population cannot participate.

Trial focus: The study explores how clozapine affects brain permeability and inflammatory markers. Participants continue their stable antipsychotic regimen and are monitored through 2029. The research examines whether specific biomarkers can predict treatment response, including analysis of inflammatory substances in blood and cerebrospinal fluid.

Medication: Clozapine is an atypical antipsychotic that works by balancing brain chemicals, particularly affecting dopamine receptors. It is specifically used for patients who have not responded well to other treatments, helping to reduce symptoms like hallucinations while improving mood and cognitive function.

Study on Cannabidiol as an Add-On Treatment for Patients with Early Schizophrenia

This German study tests cannabidiol as an additional treatment for individuals in the early stages of schizophrenia. Cannabidiol is a non-intoxicating compound found in cannabis plants that may offer mental health benefits without causing a “high.”

Inclusion criteria: Participants must be 18-65 years old with a confirmed DSM-IV-TR diagnosis of schizophrenic psychosis. They must be on a stable dose of specific atypical antipsychotic medications for at least two weeks, have a PANSS total score of 75 or less, and speak German or English fluently. Women of childbearing potential must use appropriate contraception, and participants must have a BMI between 18 and 40.

Exclusion criteria: Those without remitted early phase schizophrenia, not receiving antipsychotic maintenance treatment, outside the age range, or belonging to vulnerable populations cannot participate.

Trial focus: The study runs for 12 months as a double-blind trial where cannabidiol is compared to placebo. Researchers assess changes in recovery markers, social functioning, and cognitive abilities, monitoring participants for side effects throughout the study period.

Medication: Cannabidiol works by interacting with the endocannabinoid system, potentially modulating neurotransmitter release and reducing psychotic symptoms. It is being studied as a potential add-on therapy to enhance recovery in early-phase schizophrenia.

Study on Clemastine and Aerobic Exercise for Improving Cognitive Function in Schizophrenia Patients

This trial examines whether combining clemastine medication with aerobic exercise can improve cognitive function in people with schizophrenia. The research focuses on myelin plasticity, which relates to the protective covering of nerve fibers in the brain.

Inclusion criteria: Participants must be 18-65 years old with a DSM-5 diagnosis of schizophrenia or related disorder, have a PANSS score of 75 or less, and be on stable antipsychotic medication for at least one week. Female participants of childbearing potential must have negative pregnancy tests and use medically approved contraception methods.

Exclusion criteria: Those with conditions other than schizophrenia, outside the age range, unable to give informed consent, pregnant or breastfeeding, with substance abuse history, serious medical conditions, participation in other trials, or recent medication changes cannot participate.

Trial focus: The 90-93 day study monitors changes in cognitive function through assessments like the Global Assessment of Functioning and n-back test. Researchers evaluate physical fitness, quality of life, and any side effects while examining how the combination therapy affects myelin and cognitive abilities.

Medication: Clemastine is an antihistamine being studied for its potential to enhance myelin plasticity and cognitive function. The trial combines it with aerobic exercise to assess whether this combination can improve memory and overall functioning in individuals with schizophrenia.

Study on Improving Social Skills in Schizophrenia Using Oxytocin or Placebo as an Add-On Treatment for Patients with Schizophrenia Spectrum Disorders

This German study tests whether oxytocin nasal spray, used alongside regular psychosocial treatment, can enhance social skills in people with schizophrenia spectrum disorders. Oxytocin is a naturally occurring hormone known for its role in social bonding.

Inclusion criteria: Participants must be 18-64 years old with confirmed schizophrenia or other primary psychotic disorders, have at least one moderate symptom on the PANSS negative subscale, and receive psychosocial treatment at least twice weekly. Women of childbearing potential and men with such partners must use highly effective contraception throughout the study and for 30 days after.

Exclusion criteria: Those without a diagnosis of schizophrenia or primary psychotic disorders, outside the age range, not receiving psychosocial treatment, or belonging to vulnerable populations cannot participate.

Trial focus: The 12-week study measures changes in personal and social performance, quality of life, and cognitive function. Participants receive either oxytocin (40 international units per milliliter) or placebo as a nasal spray, administered alongside their existing psychosocial treatment.

Medication: Oxytocin is a neuropeptide hormone administered intranasally. It is being studied for its potential to influence social behavior by acting on specific brain receptors, which may help modulate social cognition and emotional responses in people with schizophrenia spectrum disorders.

Study on Semaglutide for Weight Control in Patients with Schizophrenia and High BMI Using Antipsychotics

This Norwegian trial investigates whether semaglutide can help manage body weight in patients with schizophrenia spectrum disorders who have a BMI of 30 or higher, or 27 or higher with prediabetes, while taking antipsychotic medications.

Inclusion criteria: Participants must be 18-70 years old with a schizophrenia-spectrum diagnosis according to ICD-10. They must have a BMI of 30 kg/m² or higher, or 27 kg/m² or higher with prediabetes confirmed by specific fasting plasma glucose or HbA1c levels measured on two separate occasions. Patients must have been using antipsychotic drugs for at least 3 weeks with plans for continued use for at least 6 months.

Exclusion criteria: Those without the specified BMI levels, without schizophrenia spectrum disorders, or without the required fasting plasma glucose or HbA1c levels cannot participate.

Trial focus: The 26-week study monitors body weight changes as the primary endpoint, with regular assessments of blood sugar levels, cholesterol, insulin levels, and other health indicators. Researchers also evaluate cognitive function and quality of life.

Medication: Semaglutide is administered as a subcutaneous injection of 2.4 mg once weekly. It is a GLP-1 receptor agonist that mimics a natural hormone helping regulate blood sugar and appetite, potentially leading to weight loss while improving overall metabolic health.

Study on Sodium Benzoate and Clozapine for Adults with Refractory Schizophrenia Symptoms

This Polish trial tests NaBen (sodium benzoate), a D-amino acid oxidase inhibitor, as an add-on treatment for adults with refractory schizophrenia whose symptoms persist despite clozapine treatment.

Inclusion criteria: Participants must be 18-55 years old with a BMI between 17 and 38, have negative drug tests, have a caregiver to support participation, and not be a danger to themselves or others. They must have doctor-confirmed schizophrenia for at least 2 years, meet criteria for refractory schizophrenia, have been taking clozapine for at least 6 months on a stable dose for 3 months, and have a PANSS score of 70 or higher. Women of childbearing potential must use effective contraception.

Exclusion criteria: Those under 18, without refractory schizophrenia, not taking clozapine, or belonging to vulnerable populations cannot participate.

Trial focus: The study runs in two parts, testing different doses of NaBen (1000 mg and 2000 mg per day) for up to eight weeks. Participants continue their clozapine treatment while researchers monitor symptom changes using various scales and assessments.

Medication: NaBen is a D-amino acid oxidase inhibitor administered orally in tablet form. It works by blocking an enzyme that breaks down certain amino acids in the brain, potentially helping improve residual symptoms of schizophrenia when combined with clozapine.

Study on the Effect of Clozapine and Drug Combination for Patients with Schizophrenia Experiencing First-Line Treatment Failure

This multi-country study (Germany, Austria, Italy, Spain) examines whether an intensified six-week medication treatment can provide better outcomes than usual treatment for individuals who have not responded well to their initial schizophrenia medication.

Inclusion criteria: Participants must be 18-70 years old, either inpatients or outpatients, with confirmed schizophrenia, schizoaffective disorder, or schizophreniform disorder. They must be experiencing first-time treatment failure on their initial medication (used for at least 4 weeks), have a CGI-I score of 3 or higher, and plan to change their medication. Women of childbearing potential must have negative pregnancy tests and use effective contraception.

Exclusion criteria: Those without the specified diagnoses or who have not experienced first-time treatment failure cannot participate.

Trial focus: The 6-week study compares intensified pharmacological treatment with treatment as usual, monitoring symptom severity changes using the PANSS scale. Researchers also evaluate anxiety, depression, quality of life, and side effects throughout the treatment period.

Medication: The study tests various medications including clozapine, ziprasidone, amisulpride, fluoxetine, perphenazine, paliperidone, aripiprazole, and others. The intensified treatment approach aims to provide more aggressive symptom management for those who haven’t responded to initial therapy.

Study on the Effectiveness and Safety of Cariprazine for Adolescents (13-17 years) with Schizophrenia

This study (Romania, Bulgaria) evaluates cariprazine’s effectiveness and safety in treating adolescents aged 13-17 with schizophrenia. Cariprazine is an atypical antipsychotic available in various doses.

Inclusion criteria: Participants must be 13-17 years old with confirmed DSM-5 schizophrenia diagnosis verified through K-SADS-PL interview. They must have a PANSS score of 70 or higher with a score of 4 or higher on at least 2 of 5 specific symptoms, and a CGI-S scale score of 4 or higher, assessed during initial visits.

Exclusion criteria: Those outside the 13-17 age range, without schizophrenia diagnosis, unable to follow study procedures, or belonging to vulnerable populations cannot participate.

Trial focus: The 6-week double-blind study compares cariprazine (either 1.5 mg or 4.5 mg daily) to placebo, with regular assessments monitoring symptom changes using PANSS and other scales. Researchers track both effectiveness and safety throughout the treatment period.

Medication: Cariprazine is an atypical antipsychotic that modulates dopamine and serotonin receptors in the brain, helping improve symptoms such as hallucinations, delusions, and disorganized thinking in adolescents with schizophrenia.

Study on the Effects of Cariprazine on Cognitive Function in Schizophrenia Patients Needing Antipsychotic Treatment Adjustment

This Austrian trial studies how cariprazine affects cognitive functioning in schizophrenia patients who need adjustments in their oral antipsychotic treatment.

Inclusion criteria: Participants must be 18-65 years old with ICD-10 schizophrenia diagnosis confirmed by M.I.N.I. interview. They must have no hospitalization or medication changes for at least 8 weeks, need adjustment of current oral antipsychotic medication as determined by their psychiatrist, have a CGI-S baseline score of 4 or higher, and be able to provide written informed consent.

Exclusion criteria: Those without schizophrenia diagnosis, outside the 18-65 age range, or belonging to vulnerable populations cannot participate.

Trial focus: The 28-week study monitors how cariprazine affects cognitive abilities through various assessments, including fMRI brain imaging to observe brain activity changes. Researchers evaluate thinking skills such as memory and attention throughout the treatment period.

Medication: Cariprazine (Reagila 1.5 mg hard capsules) is an atypical antipsychotic administered orally once daily. It modulates specific neurotransmitter receptors in the brain, potentially improving cognitive outcomes in individuals requiring medication adjustments.

Study on the Effects of Tirzepatide on Reducing Alcohol Intake in Patients with Schizophrenia and Alcohol Use Disorder

This Danish study explores whether tirzepatide can help reduce alcohol consumption in patients diagnosed with both schizophrenia and alcohol use disorder.

Inclusion criteria: Participants must be 18-70 years old with confirmed diagnoses of both alcohol dependence/use disorder and schizophrenia spectrum disorder according to ICD-10 and DSM-5. They must have an AUDIT score greater than 15, BMI of 23 or higher, and have had 4 or more heavy drinking days within a 21-day period during the 28 days before the study. Informed consent is required.

Exclusion criteria: Those without both diagnoses, outside the age range, unwilling or unable to comply with procedures, with interfering medical conditions, pregnant or breastfeeding, participating in other trials, or with severe allergies to study medications cannot participate.

Trial focus: The 26-week study monitors changes in heavy drinking days as the primary outcome, with assessments of alcohol cravings, overall consumption, and quality of life. Some participants undergo additional fMRI scans to study brain activity related to alcohol cues.

Medication: Tirzepatide is administered as a subcutaneous injection using a pre-filled pen. Dosages range from 2.5 mg to 15 mg per dose, given once weekly for 16 weeks with possible extension to 26 weeks. It is a dual agonist targeting receptors involved in glucose and appetite regulation.

Study on Vafidemstat for Treating Negative Symptoms and Cognitive Impairment in Adults with Schizophrenia

This Spanish trial tests vafidemstat’s effectiveness in reducing negative symptoms and improving cognitive function in adults with schizophrenia. Negative symptoms include lack of motivation and social withdrawal, while cognitive impairment affects memory and problem-solving.

Inclusion criteria: Participants must be 18-55 years old, medically stable, able to read and write fluently with good hearing and vision, and have negative Covid-19 tests if precautions are in place. They need a study partner spending at least 4 hours weekly with them, have stable living environment for over 6 months, and use effective contraception if fertile. They must have schizophrenia confirmed by specific interview, persistent negative symptoms with minimal positive symptoms, stable symptoms for 3 months, and be outpatients with stable medication for 3 months. BMI should be 18.5-35 kg/m² (with review for 35-40 kg/m²).

Exclusion criteria: Those without schizophrenia diagnosis, under 18, or belonging to vulnerable populations cannot participate.

Trial focus: The 24-week double-blind study compares vafidemstat to placebo, with regular assessments using PANSS and BACS scales. Researchers monitor symptom changes, cognitive function improvements, and any side effects throughout the study period.

Medication: Vafidemstat is a psychiatric medication administered orally in tablet form. It modulates certain brain enzymes, potentially improving mood and cognitive functions in people with schizophrenia, specifically targeting negative symptoms and cognitive impairment.

Summary

This overview presents 30 ongoing clinical trials for schizophrenia, representing a diverse international research effort. The trials span across Europe, with notable concentrations in Spain (10 trials), Germany (9 trials), and Italy (5 trials), reflecting strong European research commitment to advancing schizophrenia treatment.

Several therapeutic approaches are being investigated. Multiple trials focus on cognitive improvement, including studies of clemastine with aerobic exercise, cariprazine, vortioxetine, tolcapone, iclepertin, and RL-007. Metabolic health management is addressed through semaglutide trials for weight control. Social functioning improvements are explored through oxytocin nasal spray studies. Treatment-resistant cases are targeted with studies on clozapine biomarkers, sodium benzoate combinations, and evenamide as add-on therapy.

Specific populations receive attention, including adolescents (13-17 years) in cariprazine safety and effectiveness studies, and patients with co-occurring alcohol use disorder in the tirzepatide trial. Novel mechanisms are being explored, such as cannabidiol’s potential neuroprotective effects, rituximab’s immunomodulatory approach, brain inflammation imaging with 18F-DPA-714, and KarXT’s muscarinic receptor targeting.

Long-term safety monitoring is prominent, with extended studies of emraclidine, iclepertin, and cariprazine over periods up to two years. The trials collectively address core symptom management, cognitive enhancement, metabolic complications, social functioning, and treatment resistance, offering hope for more personalized and effective treatment approaches for individuals living with schizophrenia.

Ongoing Clinical Trials on Schizophrenia

  • A study to evaluate the effectiveness and safety of NBI-1117570 in adults with schizophrenia who require hospital treatment.

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    Bulgaria Poland Romania

  • Study on the Effects of GT-002 and Oxazepam for Cognitive Impairment in Schizophrenia Patients

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    Denmark

  • Study on Brain Inflammation in Schizophrenia Patients Using 18F-DPA-714

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    France

  • Study on Melatonin and Quetiapine for Treating Insomnia in Adolescents with Psychiatric Disorders

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    Denmark

  • Study on the Effects of Tirzepatide on Reducing Alcohol Intake in Patients with Schizophrenia and Alcohol Use Disorder

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    Denmark

  • Study on the Effectiveness of Aripiprazole and Paliperidone in Patients Experiencing Their First Episode of Schizophrenia

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    Spain

  • Study on Clemastine and Aerobic Exercise for Improving Cognitive Function in Schizophrenia Patients

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    Germany

  • Study on Improving Social Skills in Schizophrenia Using Oxytocin or Placebo as an Add-On Treatment for Patients with Schizophrenia Spectrum Disorders

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    Germany

  • Study on the Effect of Clozapine and Drug Combination for Patients with Schizophrenia Experiencing First-Line Treatment Failure

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    Austria Germany Italy Spain

  • Study on Vafidemstat for Treating Negative Symptoms and Cognitive Impairment in Adults with Schizophrenia

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    Bulgaria Poland Romania Slovakia Spain

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