Health Condition 1: F28- Other psychotic disorder not due to a substance or known physiological condition
Conditions
Interventions
Intervention1: NW3509: Fixed oral doses of 7.5, 15 mg BID orally for 6 weeks therapy of NW-3509 (Evenamide)
Control Intervention1: NW3509: Fixed oral doses of 30 mg BID orally for 6 weeks therapy of N
Sponsors
Newron Pharmaceuticals SpA
CliniRx Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Psychiatric 3. Meets current DSM-5 criteria for schizophrenia. Other psychiatric disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia. [see Exclusion criteria below] 4. Has been diagnosed with schizophrenia within the past 10 years. 5. Has shown treatment-resistance according to psychiatric history, with the last failed treatment documented in the patient’s clinical records. “Treatment-resistant Schizophrenia ? (TRS) is defined as a persistence of significant clinical symptoms despite adequate doses of two standard antipsychotic medications (other than clozapine) from two different chemical classes, including at least one atypical antipsychotic, for at least 6 weeks of treatment each. The last failed treatment trial must be documented. 6. Has a Clinical Global Impression – Severity of disease (CGI-S) rating of moderately ill to severely ill (score of 4 to 6 [scale 1-7]). 7. Has a PANSS total score = 70 at screening and baseline. 8. Has a score of 4 (moderate) or more on at least 2 of the following 4 PANSS symptoms of psychosis: P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P6 (Suspiciousness/Persecution) and G9 (Unusual Thought Content); and a total score of at least 20 on the combined total of the PANSS symptom items: P1 (Delusions), P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P4 (Excitement), P6 (Suspiciousness/Persecution), P7 (Hostility), and G9 (Unusual thought content). 9. Has a Global Assessment of Functioning (GAF) scale total score = 50. 10. Is in need of anti-psychotic treatment and is currently receiving mono-therapy at a stable dose (minimally for 4 weeks prior to screening) at a minimal recommended therapeutic or higher dose of one antipsychotic (atypical or typical, other than clozapine). Current use of quetiapine at a dose of 150 mg or less at night as a soporific will not be considered polypharmacy. 11. Current level of symptoms has been present for at least one month, but not exceeding one year.
Exclusion criteria
Exclusion criteria: Psychiatric 1. DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder (depression will be assessed at screening and baseline using the Calgary Depression Scale for Schizophrenia (CDSS); a score of 7 or higher will be exclusionary). 2. History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of ‘moderate’ or ‘severe’, or patient is currently abusing drugs or alcohol or has done so in the past year. A history of nicotine or caffeine dependence is acceptable; and patients testing positive for THC on the urine drug screen will not be excluded from the study unless there is evidence of toxic psychosis. 3. Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric daycare, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study. 4. Has a PANSS total score > 90 or a CGI-S rating of 7 (among the most extremely ill patients). 5. History or current diagnosis of other psychiatric or behavioral disorders that may interfere with the conduct or interpretation of the study. 6. Known suicidal risk, or a suicide attempt within the past 2 years, as assessed by the CDSS and/or by psychiatric history. 7. History of neuroleptic malignant syndrome, priapism or moderate or severe tardive dyskinesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid) in patients with treatment-resistant schizophrenia not responding adequately to a stable, therapeutic doses of their current antipsychotic medication.Timepoint: 6 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate preliminary efficacy of the three fixed doses of evenamide, based on symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Change from baseline (CGI-C) and Severity of illness (CGI-S); • To determine the effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale.Timepoint: 6 weeks | — |
Countries
India, Italy, Malaysia, Sri Lanka
Contacts
Public ContactShiv Issar
CliniRx Research Pvt Ltd
Outcome results
None listed