Treatment for Schizophrenia in Adolescents 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 12 and 17 years of age inclusive 2. Physician confirmed DSM-IV or -V diagnosis of schizophrenia based on the MINI International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies for Children and Adolescents, version 6.0 (MINI-KID, Version 6.0) (Sheehan, 2010) (refer to Appendix 19.1) 3. Are clinically stable with residual symptoms. Residual symptoms will be defined as a total score of = 60 of PANSS and a score of = 40 for SANS 4. An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to randomization into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole (Maintena®) and Paliperidone (Xeplion®); six (6) months for Olanzapine pamoate monohydrate (Zypadhera®); and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics) 5. In good general physical health and all physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and electrocardiogram [ECG]) are clinically unremarkable per the Investigator 6. Subject has a negative urine illicit drug screening test 7. Subject understands and is willing to sign the IAF prior to study entry and agrees to be available for all the study visits 8. The subject’s guardian understands and is willing to sign the ICF prior to study entry and agrees to be available for all the study visits 9. Must not be a danger to self or others and must have family support available to be maintained as outpatients Are the trial subjects under 18? yes Number of subjects for this age range: 126 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from randomization into the study: 1. Meets the DSM-IV or -V criteria at screening for mental retardation, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder. Other comorbid disorders; e.g., attention-deficit hyperactivity disorder (ADHD), are allowed as long as schizophrenia is the primary diagnosis and the comorbid disorder(s) do not require medication. 2. Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose 3. History of epilepsy, head trauma, or neurological illness other than Tourette’s syndrome 4. History of allergic reaction to sodium benzoate 5. Serious medical illnesses such as acute or chronic renal disease, liver failure or heart disease that, in the opinion of the Investigator, may interfere with the conduct of the study. 6. Current substance abuse or positive urine illicit drug screening or history of substance dependence (including alcohol, but excluding nicotine and caffeine) in the past three (3) months. 7. Inability to follow protocol 8. Body Mass Index (BMI) > 35 9. Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening Visit) or are nursing, or who do not agree to abstinence or birth control during the study 10. Cancer within the last three (3) years except for basal cell carcinoma and squamous cell carcinoma 11. Previous participation in an intervention trial within 30 days of randomization 12. Decrease in the PANSS total score by more than 10 percent using PANSS evaluations performed at Screening Visit 1 and Screening Visit 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study has two portions: Phase IIb and Phase III: The primary objective of the Phase IIb portion of this study is to evaluate NaBen® (sodium benzoate) (1000 mg/day) safety and effectiveness and to determine the final sample size needed in order to proceed with the Phase III part of this trial. The primary objective of the Phase III portion of this study is to evaluate the effectiveness of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day), in improving the negative and positive symptoms associated with schizophrenia in adolescents.;Secondary Objective: This study has two portions: Phase IIb and Phase III: Phase IIb – The secondary objective of this portion of the study is to evaluate the safety and tolerability of NaBen® (sodium benzoate) (1000 mg/day) as compared to Placebo (0 mg/day). Phase III – The secondary objective of this portion of the study is to evaluate the safety and tolerability of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day).;Primary end point(s): The primary efficacy endpoint for the study is: Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after six (6) weeks of treatment;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SECONDARY EFFICACY ENDPOINTS • Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score from baseline after 6 weeks of treatment • Percentage of subjects with 20% or more reduction in Positive and Negative Syndrome Scale (PANSS) total score from baseline after six (6) weeks of treatment • Percent change in Positive and Negative Syndrome Scale (PANSS) subscales • Percent change in Scale for Assessment of Negative Symptoms (SANS) total scores • Percent change in Scale for Assessment of Negative Symptoms (SANS) subscale scores ADDITIONAL EFFICACY ENDPOINTS • Percent change in Children's Global Assessment Scale (CGAS) • Percent change in Clinical Global Impression-Severity (CGI-S) • Percent change in Children's Depression Rating Scale-Revised (CDRSR) 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 (SAS) scale • 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 ECG parameters over time;Timepoint(s) of evaluation of this end point: After 6 weeks of randomized treatment | — |
Countries
Bulgaria, Canada, Poland, Taiwan, United Kingdom, United States
Contacts
Public ContactContract Research Organisation
Amarex Clinical Research, LLC
Outcome results
None listed