SEP-363856 for Schizophrenia
This study is evaluating whether an investigational drug may help improve symptoms of schizophrenia.
See full descriptionAbout 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.
About The Treatment
Side Effect Profile for SEP-363856
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.