What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics like aripiprazole, risperidone, olanzapine, and quetiapine, are associated with side effects such as weight gain, metabolic syndrome (including diabetes and dyslipidemia), and sedation. While these medications generally cause fewer extrapyramidal symptoms compared to first-generation antipsychotics, they still carry risks. Olanzapine, for instance, is more likely to cause significant weight gain and metabolic issues, whereas aripiprazole and risperidone have a relatively favorable side effect profile but can still lead to some metabolic changes.

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. Typical antipsychotics like haloperidol and chlorpromazine were among the first to be approved. Atypical antipsychotics, which tend to have a more favorable side effect profile, include drugs like clozapine, risperidone, olanzapine, quetiapine, and aripiprazole. Aripiprazole, in particular, has been extensively studied and is known for its unique pharmacodynamic properties, making it a common choice for augmenting treatment in patients with residual symptoms. These medications are similar to the investigational drug being studied for long-term safety and tolerability in people with schizophrenia.

What other types of research exist?

Promising novel alternatives for schizophrenia treatment in 2024 include: 1) New-generation antipsychotics such as brexpiprazole and cariprazine, which have shown efficacy with potentially lower side effects. 2) Agents targeting cognitive impairments, like those developed under the MATRICS initiative. 3) Psilocybin-assisted psychotherapy, which has shown potential in treatment-resistant cases. 4) Noninvasive brain stimulation techniques, which are being explored for their efficacy in managing negative symptoms of schizophrenia.

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Other

Investigational Drug 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

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 medication called SEP-363856 for people with schizophrenia who were in earlier studies. It aims to see if the drug is safe and can be tolerated over an extended period.

Who is the study for?

This trial is for males and females aged 13-65 with schizophrenia who've completed prior studies SEP361-301 or SEP361-302. Participants must not be pregnant, agree to use effective birth control, and have used only allowed medications for schizophrenia during previous studies.

What is being tested?

The study tests the long-term safety of a new drug called SEP-363856 over one year. It's open to those previously in related trials and will take place across roughly 80 global centers.

What are the potential side effects?

While specific side effects are not listed here, they typically include any negative reactions participants experience from the investigational drug throughout the trial duration.

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

SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily

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, particularly second-generation antipsychotics, work by modulating neurotransmitter activity in the brain, especially dopamine and serotonin pathways. This helps to reduce symptoms like hallucinations, delusions, and disorganized thinking. Understanding these mechanisms is important for patients as it guides the choice of treatment, balancing effectiveness with side effects, and aiming to enhance overall quality of life and daily functioning.

Psychosocial interventions for people with schizophrenia or psychosis on minimal or no antipsychotic medication: A systematic review.Treatment of early onset schizophrenia: recent trends, challenges and future considerations.Using the needs of WHO to prioritise Cochrane reviews: The case of antipsychotic drugs.