What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics (SGAs) like aripiprazole and risperidone, are preferred due to their lower risk of extrapyramidal symptoms (EPS) compared to first-generation antipsychotics (FGAs). However, SGAs can still cause side effects such as weight gain, metabolic syndrome, and increased prolactin levels. FGAs, while effective, are more likely to cause EPS, including akathisia, dystonia, and parkinsonism, as well as tardive dyskinesia. Both classes of antipsychotics can also lead to sedation, anticholinergic effects (e.g., dry mouth, constipation), and cardiovascular issues. SEP-363856, which likely modulates dopamine and serotonin pathways, may share some of these side effects, but specific data on its side effect profile would be needed for a precise comparison.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of schizophrenia, primarily focusing on the modulation of neurotransmitter systems such as dopamine and serotonin pathways. First-generation antipsychotics like haloperidol and chlorpromazine primarily target dopamine receptors. Second-generation antipsychotics, including risperidone, olanzapine, and clozapine, offer a broader mechanism of action by affecting both dopamine and serotonin receptors, which can result in fewer motor side effects and improved efficacy for negative symptoms. Newer agents like aripiprazole and brexpiprazole act as partial agonists at dopamine D2 and serotonin 5-HT1A receptors, providing a more balanced neurotransmitter modulation. These treatments aim to manage the symptoms of schizophrenia effectively while minimizing side effects.

What other types of research exist?

Promising novel alternatives to SEP-363856 for schizophrenia treatment include: 1) T-773, which activates the prefrontal cortex and improves cognition, showing antipsychotic-like effects through partial activation of D1- and D2-MSNs. 2) Compound 26, a fluorinated imidazo[1,2-a]pyridine derivative, which has shown antipsychotic-like activity in animal models with a non-dopaminergic mechanism. 3) TAK-063, a PDE10A inhibitor, which provides potent antipsychotic-like effects through balanced activation of direct and indirect striatal pathways.

← Back to Search

Unknown

SEP-363856 for Schizophrenia

Phase 1

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 to10 weeks

Awards & highlights

Summary

This trial is studying a new drug for schizophrenia to see if it has physical dependence. Participants aged 18-65 are needed in 6 US sites for 10 weeks.

Who is the study for?

Adults aged 18-65 with schizophrenia, who are relatively stable (not severely ill) and have been on antipsychotic medication for at least 6 weeks can join this study. They must not be at risk of suicide or self-harm, nor have other mental health diagnoses besides schizophrenia.Check my eligibility

What is being tested?

The trial is testing SEP-363856 to see if it causes physical dependence compared to a placebo. Participants will be randomly assigned to receive either the drug or a placebo over approximately 10 weeks across six sites in the US.See study design

What are the potential side effects?

Potential side effects are not detailed here, but generally, antipsychotics can cause drowsiness, weight gain, dry mouth, restlessness and sometimes more serious side effects like movement disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum change from the steady-state baseline (CSSBmax) in the total score of the 20 item Physician Withdrawal Checklist (PWC-20) during the 7-day Randomized Withdrawal Period

Side effects data

From 2020 Phase 2 trial • 39 Patients • NCT02969369

22%

Hallucination

19%

Fall

19%

Dizziness

16%

Confusional state

13%

Nausea

Somnolence

Anxiety

Delusion

Insomnia

Hypotension

Fatigue

Urinary tract infection

Aggression

Agitation

Pain

Hypertension

Corneal abrasion

Asthenia

Balance disorder

Hip fracture

Mental disorder

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

SEP-363856

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SEP-363856Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 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

The most common treatments for schizophrenia primarily involve antipsychotic medications that modulate neurotransmitter systems, particularly dopamine and serotonin pathways. Typical antipsychotics, such as haloperidol, primarily block dopamine D2 receptors, reducing the positive symptoms of schizophrenia like hallucinations and delusions. Atypical antipsychotics, such as clozapine and risperidone, target both dopamine and serotonin receptors, which helps in managing both positive and negative symptoms, including social withdrawal and apathy. The modulation of these neurotransmitter systems is crucial as it helps to balance the chemical imbalances in the brain that are believed to contribute to the symptoms of schizophrenia, thereby improving overall functioning and quality of life for patients.

Potential Utility of Biased GPCR Signaling for Treatment of Psychiatric Disorders.The antipsychotic landscape: dopamine and beyond.Dose-response relationships for the antipsychotic effects and Parkinsonian side-effects of typical neuroleptic drugs: practical and theoretical implications.