SEP-363856 for Schizophrenia

Recruiting at 44 trial locations

Overseen By Otsuka Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Must be taking: Antipsychotics

Disqualifiers: Alcohol use, Substance use, Bipolar, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

522 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is SEP-363856 safe for humans?

SEP-363856 is a new type of medication for schizophrenia that works differently from traditional drugs, which often have side effects due to dopamine receptor blocking. Early studies suggest it might avoid these common side effects, but more research is needed to fully understand its safety in humans. ^{1 2 3 4 5}

What makes the drug SEP-363856 unique for treating schizophrenia?

SEP-363856 is unique because it works differently from most antipsychotic drugs by not blocking dopamine D2 receptors, which are often associated with side effects. Instead, it targets trace amine-associated receptor 1 and serotonin 5-HT1A receptors, potentially offering effective treatment with fewer side effects. ^{1 2 3 5 6}

What is the purpose of this trial?

This is a Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia

Eligibility Criteria

This trial is for adults aged 18-65 with schizophrenia, who are experiencing a recent worsening of symptoms and have responded well to antipsychotic treatment in the past year. They must be hospitalized or require hospitalization due to acute symptoms but haven't been hospitalized for more than two weeks at screening time.

Inclusion Criteria

My mental health has recently worsened significantly.

I responded well to antipsychotic treatment in the past year.

My symptoms worsened in the last 2 months.

Exclusion Criteria

Participant has had a decrease of ≥ 20% on the PANSS total score between screening and baseline

Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia

Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SEP-363856 or placebo for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• SEP-363856

Trial Overview The study tests SEP-363856 against a placebo in people with acute schizophrenia. It's a phase 3 trial, meaning it's advanced in testing the drug's effectiveness and safety. Participants will be randomly assigned to either the drug or placebo without knowing which one they receive.

Participant Groups

Group I: SEP-363856 75 mg Experimental Treatment 1 Intervention

SEP-363856 75 mg/day

Group II: SEP-363856 100 mg Experimental Treatment 1 Intervention

SEP-363856 100 mg/day

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Recruited

170,000+

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

Findings from Research

In a study of 450 patients with schizophrenia receiving placebo injections, a 10%-15% reduction in the PANSS total score after the first week was found to be a strong predictor of long-term response at week 9, indicating that early improvements can help identify potential placebo responders.

Patients with better judgment and insight at baseline (lower PANSS G12 scores) were also more likely to show a placebo response, suggesting that certain demographic and clinical characteristics may influence the effectiveness of placebo treatments in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Placebo Improvement Is a Marker for Subsequent Placebo Response in Long-Acting Injectable Antipsychotic Trials for Schizophrenia: Combined Analysis of 4 RCTs. Kumagai, F., Suzuki, T., Fleischhacker, WW., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

SEP-363856, a Novel Psychotropic Agent with a Unique, Non-D2 Receptor Mechanism of Action. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[An antipsychotic without dopamine receptor blockade?] [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Co-Treatment of Olanzapine with SEP-363856 in Mice Models of Schizophrenia. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Early Placebo Improvement Is a Marker for Subsequent Placebo Response in Long-Acting Injectable Antipsychotic Trials for Schizophrenia: Combined Analysis of 4 RCTs. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Towards Novel Treatments for Schizophrenia: Molecular and Behavioural Signatures of the Psychotropic Agent SEP-363856. [2021]