Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.

Key facts

Study ID

NCT01908192

Run by

SyneuRx International (Taiwan) Corp

People needed

60

Starts

2014-06-01

Expected to finish

2023-10-26

Last updated by the study team

2024-05-09

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects who are between 12 and 17 years of age inclusive
• Physician confirmed DSM-IV or -V diagnosis of schizophrenia based on MINI International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies for Children and Adolescents, version 6.0 (MINI-KID, Version 6.0)
• Are clinically stable with residual symptoms, defined as a total score of ≥ 60 of PANSS and a score of ≥ 40 for SANS
• 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)
• In good general physical health and all physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) are clinically unremarkable per the investigator
• Subject has a negative urine illicit drug screening test
• Subject understands and is willing to sign the Informed Assent Form (IAF) prior to study entry and agrees to be available for all the study visits
• The subject's guardian understands and is willing to sign the Informed Consent Form (ICF) prior to study entry and agrees to be available for all the study visits
• Must not be a danger to self or others and must have family support available to be maintained as outpatients

You may not qualify if…

• 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.
• Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose
• History of epilepsy, head trauma, or neurological illness other than Tourette's syndrome
• History of allergic reaction to sodium benzoate
• 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.
• 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.
• Use of depot antipsychotics in the past six (6) months
• Inability to follow protocol
• Body Mass Index (BMI) > 35
• 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
• Cancer within the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
• Previous participation in an intervention trial within 30 days of randomization
• Subjects whose PANSS score has decreased more than 10 percent during the Screening Phase

Where it is running

• Harmonex Neuroscience Research — Dothan, Alabama, United States
• CiTrials — Bellflower, California, United States
• Renew Behavioral Health, Inc. — Long Beach, California, United States
• CiTrials — Riverside, California, United States
• Institute of Living/Hartford Hospital — Hartford, Connecticut, United States
• Children's National Health System — Washington D.C., District of Columbia, United States
• Premier Clinical Research Institute — Miami, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• John Hopkins University - Hugo W Moser Research Institute at Kennedy Krieger Inc. — Baltimore, Maryland, United States
• University of Massachusetts Medical School - Psychiatry Department — Worcester, Massachusetts, United States
• Michigan Clinical Research Institute — Ann Arbor, Michigan, United States
• University of Minnesota Medical Center - Department of Psychiatry — Minneapolis, Minnesota, United States
• Precise Research Centers — Flowood, Mississippi, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• University of Cincinnati - Dept. of Psychiatry and Behavioral Neuroscience — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Focus and Balance LLC — San Antonio, Texas, United States
• Pacific Institute of Medical Sciences — Bothell, Washington, United States
• Zain Research, LLC — Richland, Washington, United States
• Chang Gung Memorial Hospital (Linkou) — New Taipei City, Taiwan
• Chang Gung Memorial Hospital (Taipei) — Taipei, Taiwan
• Veteran General Hospital Taipei — Taipei, Taiwan

Full record on ClinicalTrials.gov

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