Treatment for Schizophrenia in Adults MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
SyneuRx International (Taiwan) Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are required to meet all of the following criteria for randomization into the study: 1. Male or female subjects who are between 18 and 55 years of age. 2. If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL. 3. Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements, , or the subject has a Legally Authorized Representative (LAR) who can provide consent to be enrolled into the study. NOTE: If the subject’s capability to provide ongoing consent during the study alters to the degree that the subject is unable to provide ongoing consent for his/her own study participation per the Investigator and the local regulations, consent should be sought from the subject’s Legally Authorized Representative (LAR) to continue in the study. If a LAR is not available the subject will be withdrawn from the study. 4. Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject’s history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0). 5. The subject is outpatient with no hospitalization for worsening of schizophrenia within 3 months of screening. If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study. 6. The subject’s schizophrenia condition is clinically stable with residual symptoms. Residual symptoms will be defined as a total score of =110 and = 60 of PANSS per Visit 1 and Visit 2 evaluations. 7. An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to screening into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole and Paliperidone; six (6) months for Olanzapine pamoate monohydrate; and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics). 8. In good general physical health and without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above twice the upper limit of normal. 9. Body Mass Index (BMI) between 17 and 35. 10. Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP). 11. The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker or nurse) as determined by the Invest
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from randomization into the study: 1. Meets the DSM-V criteria at screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation. 2. Subjects whose illness was resistant to antipsychotics according to prior treatments of two different antipsychotics of adequate dose. 3. Subjects who have been previously treated with clozapine or are currently receiving clozapine. 4. Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to screening. 5. Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to screening. 6. The subject has previously received NaBen®. 7. History of epilepsy, major head trauma, or any neurological illness other than Tourette’s syndrome which might impair the subject’s cognition or psychiatric functioning per the investigator’s judgment. 8. History of allergic reaction to sodium benzoate. 9. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study. 10. Any significant gastrointestinal disorders that, in the opinion of the investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate. 11. Any movement disorder that might affect the ratings on the EPS scales (e.g. Parkinson’s disease) or any movement disorder that is due to antipsychotic medications and is not currently controlled with anti-EPS medications 12. Current substance abuse or history of meeting criteria for moderate or severe substance abuse and/or substance dependence (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to screening. 13. Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening Visit) or are breast feeding. 14. History of cancer not in remission for the last three (3) years except for basal cell carcinoma and squamous cell carcinoma 15. Participation in a clinical trial within 3 months prior to screening or more than two clinical trials within 12 months. 16. Electroconvulsive Therapy (ECT) within six (6) months prior to screening 17. The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to screening (e.g. individual psychotherapy, cognitive behavioral therapy or rehabilitative therapy). 18. The subject’s anti-EPS medications dose or regimen has changed within 2 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effectiveness of NaBen® (sodium benzoate) (1000 mg/day) compared to Placebo (0 mg/day), in improving symptoms associated with schizophrenia in adults.;Secondary Objective: The secondary objective of of the study is to evaluate the safety, tolerability and pharmacokinetics of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day);Primary end point(s): Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks of randomized treatment ;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints • Percent change from baseline in PANSS total score after 8 weeks of treatment • Percentage of subjects with 20% or more reduction from baseline in PANSS total score after 8 weeks of treatment • Percent change in PANSS sub-scales and Marder PANSS factor scores after 8 weeks of treatment • Percent change of Personal and Social Performance (PSP) scale after 8 weeks of treatment Additional Efficacy Endpoints • Maintenance of treatment effect for PANSS total score • Maintenance of treatment effect in PSP scale • Percent change and maintenance of treatment effect in Schizophrenia Quality of Life Scale (SQLS) • Percent change and maintenance of treatment effect in Clinical Global Impression-Severity (CGI-S) and -Improvement (CGI-I) • Percent change in Hamilton Depression Rating Scale (HDRS) • Serum pharmacokinetic evaluations • Serum DNA evaluations • Serum neurotransmitter markers evaluations Safety Assessments • Incidence of Treatment-Emergent Adverse Events (TEAE) • Incidence of withdrawals from the study due to TEAEs • Percent change in Simpson-Angus extrapyramidal side effects Scale (SAS) • Percent change in Abnormal Involuntary Movement Scale (AIMS) • Percent change in Barnes Akathisia Rating Scale (BARS) • Assessment of suicidality per the Columbia-Suicide Severity Rating Scale (C-SSRS) • Changes and shifts in laboratory measurements over time • Changes in vital signs and weight over time • Changes in electrocardiogram (ECG) parameters over time;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment | — |
Countries
Bulgaria, Canada, Germany, Poland, Taiwan, United Kingdom, United States
Contacts
Public ContactContract Research Organisation
Amarex Clinical Research, LLC
Outcome results
None listed