A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Recruiting at 62 trial locations

Overseen By CNS Medical Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sunovion

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

464 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called SEP-363856 to see if it helps adults with severe schizophrenia symptoms. The drug aims to make people feel better by reducing their symptoms.

Will I have to stop taking my current medications?

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

How is the drug SEP-363856 different from other drugs for this condition?

SEP-363856, also known as Ulotaront, is unique because it works differently from traditional antipsychotics by targeting the TAAR1 receptor (a protein in the brain involved in mood and behavior) rather than the dopamine receptors, which are commonly targeted by other drugs. This novel mechanism may offer benefits for patients who do not respond well to existing treatments. ^{1 2 3 4 5}

Research Team

CNS Medical Director

Principal Investigator

Sumitomo Pharma America, Inc.

Eligibility Criteria

Inclusion Criteria

Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.

Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing.

You are experiencing significant decline in one or more areas of your daily functioning.

Exclusion Criteria

Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment

Subject is at significant risk of harming self, others, or objects based on Investigator's judgment

Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Treatment

Participants receive either SEP-363856 (75 mg or 100 mg) or placebo once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Placebo
• SEP-363856

Participant Groups

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

SEP-363856 75mg dosed once daily

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

SEP-363856 100mg dosed once daily

Group III: Placebo Placebo Group 1 Intervention

Placebo dosed once daily

Who Is Running the Clinical Trial?

Sunovion

Lead Sponsor

Trials

190

Recruited

48,900+

Dr. Armin Szegedi

Sunovion

Chief Medical Officer since 2023

MD from Semmelweis University

Dr. Antony Loebel

Sunovion

Chief Executive Officer since 2019

MD from Washington University School of Medicine

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

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

The mouthrinse containing 0.05% CHX and 0.05% CPC significantly reduced plaque levels in patients with poor oral hygiene over a 3-month period, indicating its efficacy in improving oral health (P<0.001).

While the mouthrinse effectively decreased plaque and bleeding on probing, it did not show a significant impact on gingival inflammation or overall patient-reported outcomes, suggesting that while it helps with plaque control, it may not fully address all aspects of gum health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower concentration of chlorhexidine and cetyl-pyridinium chloride mouthwash demonstrates some efficacy. Lamont, T.[2012]

In a clinical trial with 73 participants suffering from rotator cuff related shoulder pain, omega-3 polyunsaturated fatty acids (PUFAs) showed a modest improvement in pain and disability outcomes, particularly noted in the Shoulder Pain and Disability Index (SPADI) at 3 months.

However, there was no significant difference in the primary outcome, the Oxford Shoulder Score (OSS), between the omega-3 group and the placebo group at the 2-month mark, indicating that while there may be some benefits, they are not robust.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of long-chain omega-3 polyunsaturated fatty acids in the management of rotator cuff related shoulder pain. Sandford, FM., Sanders, TA., Wilson, H., et al.[2022]

The C1-C2 self-sustained natural apophyseal glide (SNAG) technique significantly improved the range of motion in the cervical spine by 15 degrees in participants with cervicogenic headaches, compared to only 5 degrees in the placebo group, indicating its effectiveness in addressing C1-C2 dysfunction.

Participants using the C1-C2 self-SNAG reported a substantial reduction in headache symptoms, with scores decreasing by 54% over 12 months, demonstrating its long-term efficacy in managing cervicogenic headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. Hall, T., Chan, HT., Christensen, L., et al.[2022]

In a study involving 10 volunteers with spinal cord injury, abdominal neuromuscular electrical stimulation (NMES) improved colonic transit in most segments but negatively impacted lung capacity, specifically forced vital capacity (FVC).

Participants in the NMES group reported higher satisfaction regarding the aesthetic effects on their abdominal wall compared to the placebo group, suggesting potential cosmetic benefits alongside functional improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation of completely paralyzed abdominal muscles in spinal cord-injured patients: a pilot study. Hascakova-Bartova, R., Dinant, JF., Parent, A., et al.[2011]

In a study involving six competitive wheelchair athletes, short-term oral creatine supplementation did not significantly improve 800 m performance compared to a placebo, indicating that creatine may not enhance performance in this specific group.

All measured parameters, including completion time, perceived exertion, lactate levels, and heart rate, showed no significant differences between the creatine and placebo conditions, suggesting that creatine supplementation may not be effective for trained, spinal cord-injured athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of creatine supplementation on 800 m wheelchair performance: a pilot study. Perret, C., Mueller, G., Knecht, H.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Lower concentration of chlorhexidine and cetyl-pyridinium chloride mouthwash demonstrates some efficacy. [2012]

2. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of long-chain omega-3 polyunsaturated fatty acids in the management of rotator cuff related shoulder pain. [2022]

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

Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation of completely paralyzed abdominal muscles in spinal cord-injured patients: a pilot study. [2011]

5. England pubmed.ncbi.nlm.nih.gov

Influence of creatine supplementation on 800 m wheelchair performance: a pilot study. [2013]