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A Phase 2 Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with Schizophrenia (STAR-1)
EU CTIS ID: 2025-524058-32-00
What this study is testing
To assess the efficacy of GXV813 compared to placebo on positive and negative symptoms in adult inpatients with schizophrenia diagnosed according to DSM-5 criteria experiencing an acute episode
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)
- 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 with onset less than 2 months before screening a. The participant requires hospitalization for this acute exacerbation or relapse of symptoms b. 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: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution)
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, Clinical Trials Version (SCID- 5-CT) at screening)
- History of treatment resistance to antipsychotic medications defined as no 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 for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United States. 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 EU CTIS; the study team decides eligibility.