Schizophrenia
Conditions
Keywords
Schizophrenia, GVX813
Brief summary
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
Interventions
DRUGGXV813
GXV813 administered orally.
DRUGPlacebo
Placebo administered orally.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Positive and Negative Symptom Scale (PANSS) total score | Baseline, Week 6 | PANSS is a 30-item rating scale used to assess the positive, negative, and general psychopathy symptoms of schizophrenia. PANSS total score ranges from 30 to 120 , where a higher score indicates greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs | Baseline to 6 weeks | Assessment of overall safety and tolerability of GXV813 versus placebo in adult inpatients with schizophrenia. This includes monitoring the occurrence and severity of adverse events, results of clinical laboratory tests, changes in vital signs, ECG findings, physical examinations. |
| Participant clinically significant response | Baseline, week 6 | Proportion of participants achieving a clinically significant response, defined as a ≥30% improvement in PANSS total score or a 1-point improvement in Clinical Global Impression-Severity (CGI-S) score from baseline at week 6, comparing GXV813 to placebo. |
| Change from baseline in PANSS positive sub-score | Baseline, week 6 | Assessment of the effect of GXV813 versus placebo on positive symptoms of schizophrenia, measured by the change from baseline in the PANSS positive sub-score at week 6., which measures symptoms that reflect an excess or distortion of normal mental functions. Each item is rated from 1 (absent) to 7 (extreme). |
| Change from baseline in PANSS negative sub-score | Baseline, week 6 | Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the PANSS negative sub-score (this sub-score is calculated by summing the ratings of seven items, each scored from 1 (absent) to 7 (extreme)) at week 6. |
| Change from baseline in Marder negative factor score | Baseline, week 6 | Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the Marder (it is a five-factor structure derived from factor analysis of PANSS data) negative factor score at week 6. |
| Change from baseline in Clinical Global Impression- Severity (CGI-S) scale | Baseline up to week 6 | Assessment of the effect of GXV813 versus placebo on overall illness severity, measured by the change from baseline in the CGI-S scale at week 6. The CGI-S scale uses a 7-point rating system, where the highest score indicates greather severity. |
| Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC) | Up to 6 weeks | The Area Under the Curve (AUC) in pharmacokinetics represents the total drug exposure over time. It is the area under the plot of drug concentration in plasma versus time following administration. |
| Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax) | Up to 6 weeks | Cmax is the highest concentration of a drug measured in plasma after administration and before the next dose. |
Countries
Bulgaria, United States
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed