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RecruitingPhase 2

Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well GXV813 works and how safe and easy to tolerate it is. It is for adults ages 18 to 65 with schizophrenia whose symptoms have recently worsened and who need hospital care.

The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 65 years old at screening.
  • You can understand the study and agree to take part.
  • A mental health exam and structured interview confirm schizophrenia as your main diagnosis.
  • You can stay in the hospital for the study, except during follow-up, and follow study instructions.
  • Your symptoms started getting worse or returned less than 2 months before screening, and you need hospital care.
  • If you are already in the hospital, you have been there for less than 2 weeks for this episode at screening.
  • Your score on a schizophrenia symptom scale is 80 to 120 at screening.
  • At least two symptoms are rated moderate or worse: false beliefs, confused thinking, seeing or hearing things that are not there, or feeling suspicious or targeted.

Who can't join

  • You had a main mental health diagnosis other than schizophrenia in the 12 months before screening.
  • Two adequate courses of antipsychotic medicine did not help enough, or you previously took clozapine because other treatments did not work.
  • You need medicines that moderately or strongly change how a liver enzyme called CYP3A4 works. This enzyme helps break down medicines.
  • You received a long-acting antipsychotic shot within 12 weeks before the study's starting visit, or within 24 weeks for INVEGA TRINZA.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participant is aged 18 to 65 years, inclusive, at screening 2. Participant is capable of providing informed consent 3. 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) 4. 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 5. Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening 1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms 2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening 6. 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 (P2; conceptual disorganization) iii. Item 3 (P3; hallucinatory behavior) iv. Item 6 (P6; suspiciousness/persecution) Exclusion Criteria: 1. 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) 2. 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 3. Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded 4. 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 criteria may apply

Study sites (7)

AR

CA

FL

  • Segal Institute for Clinical Research · Miami, FL 33016Rishi Kakar · Principal investigatorMore trials in Miami

GA

IL

  • Uptown Research Institute LLC · Chicago, IL 60640John Sonnenberg · Principal investigatorMore trials in Chicago
  • Pillar Clinical Research LLC · Chicago, IL 60641Scott Bartley · Principal investigatorMore trials in Chicago

MO