What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics (SGAs), are associated with side effects such as weight gain, metabolic syndrome, sedation, and increased prolactin levels. Novel antipsychotics like SEP-363856, which target trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors, may offer a different side effect profile, potentially reducing the risk of extrapyramidal symptoms (EPS) and metabolic issues. However, the specific side effects of SEP-363856 are still being studied.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (typical) and second-generation (atypical) antipsychotics. Notable atypical antipsychotics include risperidone, olanzapine, quetiapine, and aripiprazole, which primarily target dopamine and serotonin receptors. SEP-363856, currently under study, represents a novel approach by targeting trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors. This mechanism is distinct from traditional antipsychotics, potentially offering new therapeutic benefits for patients with schizophrenia.

What other types of research exist?

Promising novel alternatives to SEP-363856 for schizophrenia treatment in 2024 include KarXT (a combination of xanomeline and trospium) which targets muscarinic receptors, and Ulotaront (SEP-363856 itself, if not yet widely available). Additionally, drugs like Lumateperone (Caplyta), which modulates serotonin, dopamine, and glutamate pathways, and Pimavanserin (Nuplazid), primarily targeting serotonin 5-HT2A receptors, are also considered promising due to their novel mechanisms and favorable safety profiles.

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SEP-363856 for Schizophrenia

Phase 3

Waitlist Available

Research Sponsored by Sunovion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new schizophrenia medication called SEP-363856 in people who have already started using it. The goal is to see if it is safe and effective over several months. The medication works by affecting brain chemicals to help reduce symptoms of schizophrenia.

Who is the study for?

This trial is for men and women with schizophrenia who have finished the SEP361-308 study. They must not have used any psychotropic drugs other than their previous antipsychotic, allowed medications during that study, and women need a negative pregnancy test at the end of it. People can't join if they're pregnant, breastfeeding, suicidal, or show significant health issues in physical exams or drug tests at the end of SEP361-308.

What is being tested?

The trial continues to assess SEP-363856's effectiveness and safety for schizophrenia patients switching from their current medication to this new one. It will take place across roughly 24 sites in North America over about 25 weeks.

What are the potential side effects?

While specific side effects are not listed here, as with most antipsychotics, potential side effects may include drowsiness, weight gain, dry mouth, restlessness and possibly others depending on individual reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 2 trial • 39 Patients • NCT02969369

22%

Hallucination

19%

Dizziness

19%

Fall

16%

Confusional state

13%

Nausea

Somnolence

Insomnia

Hypotension

Delusion

Anxiety

Fatigue

Agitation

Hypertension

Aggression

Pain

Urinary tract infection

Balance disorder

Hip fracture

Mental disorder

Asthenia

Corneal abrasion

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

SEP-363856

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SEP-363856Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SEP-363856

2016

Completed Phase 3

~950

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia primarily target dopamine D2 receptors to alleviate psychotic symptoms. First-generation antipsychotics (FGAs) are effective but often cause movement disorders due to strong dopamine antagonism. Second-generation antipsychotics (SGAs) also target serotonin receptors, which can reduce side effects and improve treatment of negative symptoms. SEP-363856, a novel antipsychotic, targets trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors, offering a different mechanism that may enhance efficacy and reduce side effects. This is crucial for schizophrenia patients as it can lead to better symptom management and improved quality of life.