CLINICAL TRIAL

SEP-363856 for Schizophrenia

Recruiting · Any Age · All Sexes · Sofia, Bulgaria

This study is evaluating whether an investigational drug may help improve symptoms of schizophrenia.

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About the trial for Schizophrenia

Treatment Groups

This trial involves 2 different treatments. SEP-363856 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.
SEP-363856
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

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

Side Effect Profile for SEP-363856

SEP-363856
Show all side effects
Headache
9%
Somnolence
7%
Schizophrenia
6%
Agitation
5%
Nausea
5%
Insomnia
3%
Anxiety
2%
Cardiovascular insufficiency
1%
Suicide attempt
0%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02969382) in the SEP-363856 ARM group. Side effects include: Headache with 9%, Somnolence with 7%, Schizophrenia with 6%, Agitation with 5%, Nausea with 5%.

Eligibility

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
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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: 53 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 53 Weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 SEP-363856 will improve 1 primary outcome in patients with Schizophrenia. Measurement will happen over the course of 53 Weeks.

The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation
53 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 causes schizophrenia?

While the link between the environment and schizophrenia is unclear, the link between schizophrenia and a family history of psychosis has been well established. Given the significant overlap between the symptoms of psychosis and negative symptoms, it is hypothesized that schizophrenia has biologically based neurological and genetic components as well as secondary psychopathology. More research is needed, however, for further investigation into the underlying biology of schizophrenia.

Anonymous Patient Answer

What is schizophrenia?

Schizophrenia is a complex neurological disorder that mainly affects the brain's circuitry and is characterized by a variety of deficits including disturbances in thought, motivation, emotion, social skills and sensory gating. Schizophrenia is a debilitating disorder, but it is one that tends to fade out of consciousness.

Anonymous Patient Answer

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

Data from a recent study suggests that schizophrenia has a relatively high annual incidence in North America and that these patients do not experience a higher risk of death.

Anonymous Patient Answer

What are common treatments for schizophrenia?

Common treatments for schizophrenia include psychoactive medication, psychotherapy, and a combination of these. In a recent study, findings showed that no single drug was more frequently prescribed to a patient than the next highest. This is not true for psychodynamic or supportive therapies.

Anonymous Patient Answer

What are the signs of schizophrenia?

Patients with more severe schizophrenia may have less positive signs and more negative symptoms. Schizophrenia patients without the paranoid subtype may also present in a less favourable clinical setting and may exhibit more negative symptoms.

Anonymous Patient Answer

Can schizophrenia be cured?

Despite the enormous medical advances of the past 50 years, the answer to the question “Can schizophrenia be cured?” remains elusive. However, we must continue to explore options to improve the outcomes.

Anonymous Patient Answer

What are the latest developments in sep-363856 for therapeutic use?

SEP-363856 is a well-tolerated drug that can be used in treatment of schizophrenia and can be an effective therapeutic modality to reduce the intensity of schizophrenic symptoms and reduce the use of antipsychotics. SEP-363856 at dosage of 0.01 mg daily is as effective as amphetamine and only modestly inferior to lurazepam in the reduction of schizophrenic symptoms. SEP-363856 at 0.2 mg daily is as effective as atypical antipsychotics and only minimally inferior to aripiprazole. SEP-363856 at a dose of 0.4 mg daily, however, is similar to placebo.

Anonymous Patient Answer

Is sep-363856 typically used in combination with any other treatments?

The most effective and well-tolerated combination of augmentation therapies in one study was that of sep-363856 and risperidone, compared to placebo. No difference was found in other patients in the study. Patients in studies should be informed of the side effects of sep-363856 as they usually are not told about possible side effects during drug trials.

Anonymous Patient Answer

Has sep-363856 proven to be more effective than a placebo?

Recent findings of the present study suggest that sep-363856 is more effective than a placebo in reducing psychotic symptoms in schizophrenic patients. If these results confirm those of our previous studies then it may be that sep-363856 as a novel agonist of the metabotropic glutamate receptor 5 could be a promising therapeutic agent for reducing symptoms of schizophrenia.

Anonymous Patient Answer

How does sep-363856 work?

Sep-363856 is a novel drug candidate with a unique mode of action, and may be a potential treatment for schizophrenia and a novel strategy in the development of more effective antipsychotic drugs. The identification of novel therapeutic strategies has been hampered by a failure to evaluate systematically the effects of antipsychotic drugs of abuse. As such, we were interested in assessing the effects of different antipsychotics at clinically relevant doses. We found that sep-363856 showed promise as a potential antipsychotic and, as such, further evaluation is warranted.

Anonymous Patient Answer

Have there been any new discoveries for treating schizophrenia?

There are many new and promising treatments that are being used in the treatment of schizophrenia. The research surrounding these treatments continues. However some drugs, devices, or processes have been proven in clinical research. The list is growing as the studies continue. Treatments include the antidepressant drugs as Clulimix-trademarked, the NMDA antagonist as ketamine, glutamate modulators, dopamine agonists, and the 5-HT antagonists as traxopentin and mirtazapine. As of now, ketamine, mirtazapine, and traxopentin have become the only ones FDA approved for this treatment, the other are only used in research.

Anonymous Patient Answer

Does schizophrenia run in families?

The study failed to find an excess of siblings with schizophrenic disorder. Although siblings may have a greater risk of schizophrenia, it still is considered to be a rare occurrence in actual families. There was a strong effect of sex. It is concluded that in families with schizophrenia the parents do not have an increased risk of schizophrenia.

Anonymous Patient Answer
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