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Study Summary
This trial will study an investigational medication in patients with schizophrenia to see if it changes how the body processes glucose and how much insulin the pancreas can make.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 39 Patients • NCT02969369Trial Design
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- The researcher believes that you may be a danger to yourself or others.You have tried to end your life in the last year before the screening.You have had thoughts of hurting yourself or taking your own life in the past month, or since your last visit.This list of criteria for participating in the study may not include all requirements.You are a man or woman between 18 and 65 years old when you agree to participate.Your antipsychotic medication dosage must not have been changed (except for minor adjustments) for at least eight weeks before the screening visit.You have been diagnosed with schizophrenia by a qualified healthcare professional using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, and the diagnosis has been confirmed using a structured clinical interview.You should have a score of 4 or less on a test that measures how severe your illness is.You must have relatively low levels of aggression and uncooperativeness, as measured by a psychiatric assessment called PANSS.
- Group 1: SEP-363856
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
In which regions are the research activities for this study being conducted?
"There are 6 clinical sites that are currently enrolling participants, located in Little Rock, Long Beach and Rogers as well as 3 additional cities. In order to minimize transportation needs for potential study members, it is recommendable that they select the closest facility."
Is enrollment open to participants in this trial?
"According to clinicaltrials.gov, this research initiative is actively searching for participants. This protocol was announced on August 30th 2022 and has been altered since November 7th of the same year."
Am I eligible to join the experiment?
"This medical trial is enrolling 24 people with schizophrenia aged between 18 and 65. Eligibility criteria include: being male or female, a primary diagnosis of schizophrenia as determined by DSM-5 (Structured Clinical Interview for DSM-5), scoring ≤ 4 on the Clinical Global Impression Scale at screening, having a PANSS total score ≤ 80 and P7/G8 scores ≤4 at Screening, not changing antipsychotic medication dose in past 8 weeks prior to Screening visit."
Has SEP-363856 been granted regulatory authorization by the FDA?
"As a Phase 1 trial, with only minimal clinical data to validate safety and efficacy, SEP-363856 was assigned a score of 1."
Is the enrollment in this trial restricted to those over 18 years of age?
"As detailed in the inclusion criteria, applicants need to be between 18 and 65 years of age. This clinical trial has 46 studies dedicated to patient under 18 while 165 are allocated for those over 65."
How many volunteers are currently participating in this experiment?
"Affirmative, clinicaltrials.gov revels that this project is actively recruiting participants since its initial posting on August 30th 2022 and recent modification on November 7th of the same year. This endeavor requires 24 individuals from 6 different research sites."
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