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Tests treatment safety and results for Schizophrenia
Official title Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
ClinicalTrials.gov ID: NCT07467993
What this study is testing
What is GXV813?
GXV813 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participant is aged 18 to 65 years, inclusive, at screening
- Participant is capable of providing informed consent
- Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric...
- Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions...
- Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening
You likely can't join if
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5...
- History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous...
- Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
- Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA...
See the full eligibility criteria
- Participant is aged 18 to 65 years, inclusive, at screening
- Participant is capable of providing informed consent
- Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical...
- Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements
- Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening
- The participant requires hospitalization for this acute exacerbation or relapse of symptoms
- If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening
- Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items: i. Item 1 (P1; delusions) ii. Item 2...
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)
- History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia
- Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
- Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline Other protocol-defined inclusion/exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Bentonville, Arkansas, United States
- Pico Rivera, California, United States
- Miami, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- Kazanlak, Bulgaria, Bulgaria
- Lovech, Bulgaria
- Sofia, Bulgaria
- Veliko Tarnovo, Bulgaria
- Vratsa, Bulgaria
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bentonville, Arkansas, United States; Pico Rivera, California, United States; Miami, Florida, United States; Decatur, Georgia, United States; Chicago, Illinois, United States; St Louis, Missouri, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.