A Phase 2 Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with Schizophrenia (STAR-1)
Key facts
- Where
- Burgas, Haskovo, Kazanlik, Lovech, Plovdiv, Sliven, Sofia, Veliko Tirnovo és Vratsa, BulgáriaSee the 10 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Bulgária
- Center For Mental Health Prof. Dr. Ivan Temkov Burgas EOODBurgas, BulgáriaTaking people
- Mental Health Center - Haskovo EOODHaskovo, BulgáriaTaking people
- Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOODKazanlik, BulgáriaTaking people
- State Psychiatric Hospital - LovechLovech, BulgáriaTaking people
- University Multiprofile Hospital For Active Treatment Saint Georgi EADPlovdiv, BulgáriaTaking people
- MBAL Dr. Ivan Seliminski Sliven ADSliven, BulgáriaTaking people
- Alexandrovska University HospitalSofia, BulgáriaTaking people
- Center For Mental Health Prof. N. Shipkovenski EOODSofia, BulgáriaTaking people
- Center Za Psihichno Zdrave Veliko Tarnovo EOODVeliko Tirnovo, BulgáriaTaking people
- Center For Mental Health Vratsa EOODVratsa, BulgáriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2025-524058-32-00
- Record updated
- 2026. április 29.
- Original description
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 episodeRead full original descriptionShow less
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)
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
Inclusion: 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).
Exclusion: 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.