CLINICAL TRIAL

SEP363856 for Schizophrenia

Waitlist Available · 18+ · All Sexes · Brasov, Romania

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

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About the trial for Schizophrenia

Treatment Groups

This trial involves 2 different treatments. SEP363856 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SEP363856
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
quetiapine XR
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview at screening (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be ≥ 1 year prior to Screening.
Subject must have a CGI-S score ≤ 4 at Screening and Baseline.
Subject must have a PANSS total score ≤ 80 at Screening and Baseline.
Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening.
Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.
Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator).
Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 52 Weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 52 Weeks.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SEP363856 will improve 1 primary outcome in patients with Schizophrenia. Measurement will happen over the course of 52 Weeks.

The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
52 WEEKS
52 WEEKS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is schizophrenia?

Schizophrenia, a chronic, debilitating, psychotic and afflicting disease, is a mental disorder that manifests itself through emotional, cognitive, emotional and social symptoms. It is caused by abnormalities in the brain development. There is no cure, only alleviation of a number of symptoms. Schizophrenia occurs in an unknown but very small percentage of the world population.

Anonymous Patient Answer

How many people get schizophrenia a year in the United States?

At the national aggregate level, 2.7 million Americans received formal psychiatric diagnoses in 2005. The incidence rate per 100,000 was higher in people age 25 to 44 (12.9) than in those age 45 to 64 (7.9). The greatest increases occurred among blacks (1.8 cases per 100,000), Hispanics (1.5), and persons age 35 to 44 (1.5). The incidence of schizophrenia was less common after age 65 (1.7) than before age 65 (3.1). The incidence of a first episode of psychosis was significantly higher after age 35 than before age 25 (6.2 per 100,000).

Anonymous Patient Answer

What causes schizophrenia?

What causes psychosis? In the future, the development of personalized treatments based on genetic or environmental factors related to schizophrenia may provide new medical approaches for the management of psychosis.

Anonymous Patient Answer

Can schizophrenia be cured?

For patients this study should provide a basis for estimating recovery rates, which are not as good in the treatment of schizophrenia as the current treatment paradigm suggests. However, there are limitations to the data. Some patients could not return for clinical follow up. As a result, we did not estimate an annual recovery rate.

Anonymous Patient Answer

What are the signs of schizophrenia?

Patients usually have a clear awareness of their problem and are aware of the social deficits and the loss of drive associated with the disorder. However, patients and caregivers often lack insight concerning the severity or the likelihood that the symptomatology may result in future social disability. This under-appraisal may lead to long-term exacerbations of their symptoms as they learn to deal with the situation by manipulating symptoms, exacerbating the problem, and avoiding social situations. When patients receive adequate support, they can regain insight and become self-aware of their need for treatment. For this reason, patients are an important target in the early detection, early intervention, and treatment of schizophrenia.

Anonymous Patient Answer

What are common treatments for schizophrenia?

Several common medical treatments for schizophrenia are used in our community but their role in health care costs is minimal. Better treatments are needed. When considering treatments, cost is a major issue and has been addressed in the provision of care guidelines. The development and evaluation of new treatments is a priority in both research and practice. New medications such as atypical antipsychotics are no doubt the treatments of choice for schizophrenia but the development of more tolerable treatments is needed. Other treatments including traditional psychosocial treatments, antidepressants, anticonvulsants and non-pharmacological interventions should be developed and evaluated in more detail at all levels of care.

Anonymous Patient Answer

Who should consider clinical trials for schizophrenia?

There is much support for studies for schizophrenia, which are needed to provide the patient with a better chance of a successful outcome. This would also help improve the diagnosis and care for the patients. However, we can not ignore the importance of informing patients about, for example, which trials they cannot participate in and how they work and would they help them much less and how we would do that. If we wanted to make a change in medical practice and thought, which if we did it, for example not knowing that schizophrenics cannot participate in some of the studies that are required and do not work is one of those studies, then the other ones we would not want to know, would not work for them (e.g.

Anonymous Patient Answer

What is the average age someone gets schizophrenia?

A study of the national population of persons with schizophrenia has not yet been conducted. In order to answer this question, the data must be collected in an unbiased manner. Future research should consider applying new statistical and methodological approaches in order to obtain unbiased, representative and reliable estimates of the prevalence of this mental disorder in the general population. Furthermore, data collection must be standardized and standardized. The findings should be adjusted to geographic location and socioeconomic status. The data should be analyzed using the latest epidemiological methods that can adequately reflect the situation in which the persons live and study their lifetime risk of developing schizophrenia.

Anonymous Patient Answer

Does schizophrenia run in families?

There is a modest amount of evidence that schizophrenia is inherited and has an inheritance pattern somewhere in between the classic Mendelian disease model and complex, polygenic human genetic models of disease. We report on the findings of three major collaborative studies that support the hypothesis that schizophrenia does have an inheritance, but also discuss the complexities of the problem and the remaining challenges. We highlight the need for more stringent criteria to distinguish genuine genetic risk in schizophrenia from spurious risk due to genetics being misidentified as the cause of schizophrenia.

Anonymous Patient Answer

What are the latest developments in sep363856 for therapeutic use?

It may be assumed that sep363856 has no effect on the course of the disease as such. The therapeutic use of this drug is no longer possible at present pending further studies.

Anonymous Patient Answer

How serious can schizophrenia be?

There is no precise answer to this question. The seriousness, degree of impairment and cost of untreated schizophrenia is a very individual response to the illness, to each person afflicted with it and their families\n

Anonymous Patient Answer

Does sep363856 improve quality of life for those with schizophrenia?

In a recent study, findings suggest that the administration of a single moderate dose (800 μg/day) of the neuroprotective compound SEP363856, administered in an extended release formulation to individuals with schizophrenia, has a positive effect on the perceived quality of life and has no significant adverse effects compared with placebo. This is a novel preliminary finding which requires replication in larger, more rigorous trials.

Anonymous Patient Answer
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