Today we’re going to look at the ongoing studies and clinical trials specific to management of schizophrenia in adults, including in acutely psychotic people with schizophrenia and relapse prevention.
The below list was curated by assessing the ongoing Phase 3 trials for migraine treatments, specific for adults, and based in the United States. The dates provided are estimates, and subject to change. The list is primarily studies that have recent results posted (12 months or less).
This series is intended to provide a preview of what new innovations are to come on a given topic, and how might the results of those studies ultimately impact clinical guidelines on the topic(s).
So now let’s jump into the list of Schizophrenia Clinical Trials!
Schizophrenia Clinical Trials
Schizophrenia Clinical Trials With Results Posted:
Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)
- The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia.
- Interventions: DRUG: Iclepertin, DRUG: Placebo
- Primary Outcomes Measures: Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment, MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition, at baseline and at week 26.
- Sponsor: Boehringer Ingelheim
A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
- The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.
- Interventions: DRUG: Iclepertin
- Primary Outcomes Measures: Occurrence of treatment emergent adverse events (TEAEs), up to 1 year and 12 days.
- Sponsor: Boehringer Ingelheim
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
- A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia.
- Interventions: DRUG: SEP-363856 50mg, DRUG: SEP-363856 75mg, DRUG: Placebo
- Primary Outcomes Measures: Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6), PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 – 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210., Baseline and Week 6.
- Sponsor: Sumitomo Pharma America, Inc.
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia
- The primary objective of this study is to evaluate the efficacy of TV-44749 in adult participants with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult participants with schizophrenia. A secondary objective is to evaluate the safety and tolerability of TV-44749 in adult participants with schizophrenia Another secondary objective of this study is to evaluate the efficacy of TV-44749 from baseline to endpoint in Period 1 in adult participants with schizophrenia.
- Interventions: DRUG: TV-44749 – Dose level 1, DRUG: TV-44749 – Dose level 2, DRUG: TV-44749 – Dose level 3, DRUG: Placebo
- Primary Outcomes Measures: Change from baseline to week 8 in the Positive and Negative Syndrome Scale (PANSS) total score, Data gathered from this assessment procedure are applied to the PANSS ratings. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. These seven points represent increasing levels of psychopathology, as follows: 1- absent 2- minimal 3- mild 4- moderate 5- moderate severe 6- severe 7- extreme., Baseline, Week 8.
- Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
- This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily in subjects with schizophrenia.
- Interventions: DRUG: Xanomeline and Trospium Chloride Capsules
- Primary Outcomes Measures: Incidence of treatment-emergent adverse events (TEAEs), From initial dose to safety follow-up visit (54 weeks) or early termination.
- Sponsor: Karuna Therapeutics
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
- This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
- Interventions: DRUG: Lumateperone 42 mg, DRUG: Placebo
- Primary Outcomes Measures: Time to first symptom relapse during the Double-blind Treatment Phase, Number of days from the randomization date to the first relapse date up to 26 weeks.
- Sponsor: Intra-Cellular Therapies, Inc.
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
- This study is to evaluate the effect and safety of Brilaroxazine in patients with acute schizophrenia compared to the placebo short and long-term. Brilaroxazine will be given at fixed doses of 15 mg or 50 mg once daily over 4 weeks, then in the long-term flexible doses 15-50mg daily over a period of 52 weeks.
- Interventions: DRUG: Brilaroxazine, OTHER: Placebo
- Primary Outcomes Measures: Double Blind Safety and Efficacy of Brilaroxazine (RP5063), decrease in Positive and Negative Symptoms Assessment total score compared to placebo from Baseline to Day 28., 28 days|Open label Safety and Efficacy of Brilaroxazine (RP5063), (brilaroxazine) tablets (at flexible doses of 15 mg or 30 mg 0r 50mg OD) in an treatment part over a period of 52 weeks in stable schizophrenia subjects. The endpoints would be incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]), 52 weeks.
- Sponsor: Reviva Pharmaceuticals
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
- A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia.
- Interventions: DRUG: SEP363856, DRUG: quetiapine XR
- Primary Outcomes Measures: The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation, 52 Weeks.
- Sponsor: Sumitomo Pharma America, Inc.
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
- This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \[BID\]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.
- Interventions: DRUG: Xanomeline and Trospium Chloride Capsules, DRUG: Placebo
- Primary Outcomes Measures: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5, The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. It takes approximately 45 to 50 minutes to administer. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms., Baseline and Week 5.
- Sponsor: Karuna Therapeutics
An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
- This is a Phase 3, multicenter, 53-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia who previously completed the treatment period of one of the two Phase 3 double-blind studies, KAR-007 or KAR-009. In this OLE study, all subjects will receive KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \[BID\]) for up to 52 weeks regardless of treatment assignment in the preceding Phase 3 acute study. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to assess the long-term efficacy and monitor trough concentrations of xanomeline and trospium after administration of KarXT.
- Interventions: DRUG: Xanomeline and Trospium Chloride Capsules
- Primary Outcomes Measures: Incidence of treatment-emergent adverse events (TEAEs), The number and percentage of participants with TEAEs will be determined, From initial dose through 7 days after the final dose (up to 53 weeks)
- Sponsor: Karuna Therapeutics
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
- A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Interventions: DRUG: SEP-363856 75mg, DRUG: SEP-363856 100mg, DRUG: Placebo
- Primary Outcomes Measures: Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6), PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 – 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210., Baseline and Week 6.
- Sponsor: Sumitomo Pharma America, Inc.
Potential Guidelines That May Be Affected Include:
There you have it – a list of Phase 3 Clinical Trials for Schizophrenia as of May 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.