Two-part Clinical Study to Evaluate the Safety and Benefits of NaBen® in Adolescents with Schizophrenia

Phase 1

Conditions: Treatment for Schizophrenia in Adolescents
MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2017-001168-39-PL

Lead Sponsor: SyneuRx International (Taiwan) Corp

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 126

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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