ADOLESCENT SCHIZOPHRENIA
SND11

The SND11 study is looking at whether a potential new medication called NaBen® is safe and effective in improving symptoms of schizophrenia in teenagers. The goal of this study is to increase treatment options available for teenagers with schizophrenia.

Low function of the N-methyl-D-Aspartate receptor (NMDAR) subtype glutamate receptor in the brain plays an important role in the pathophysiology of schizophrenia. Enhancing NMDAR-mediated brain signaling is considered a novel treatment approach in improving schizophrenia associated symptoms. One method to enhance NMDA function is to raise the levels of D-amino acid (DAA) by reducing their metabolism via DAA oxidase (DAAO) inhibitors. NaBen® is a readily available DAAO inhibitor with a well- developed safety profile, and has received the FDA orphan product designations for the indications of schizophrenia in the pediatric population and patients with refractory schizophrenia receiving clozapine therapy. NaBen® is also designated as a breakthrough therapy in adult schizophrenia. Previous studies have shown excellent efficacy and safety for NaBen® in improving schizophrenia symptoms. This multi-center, randomized, placebo- controlled, parallel-group study is to further assess the safety and efficacy of NaBen® in improving symptoms of adolescent schizophrenia.

Teenagers joining the study will need to visit the study center several times during a period of up to 10 weeks. There will be a total of 7 visits during the 10 weeks including screening, double-blind treatment and follow-up phases. A parent, legal guardian, or caregiver will need to accompany them to every visit. The study is divided into three phases:

• Screening phase (2 weeks)
• Treatment phase (6 weeks)
• Follow-up phase (2 weeks)

At each visit, the study doctor will ask questions about the schizophrenia symptoms. Overall health will be monitored throughout the study using:

• physical examinations
• blood pressure and heart rate, EKG tests
• blood and urine tests

The cost of all study-related health assessments and study medication in the study will be covered. During this study your child will not be taken off their current medication. NaBen® will be added to their current treatment as an additional.

Major Inclusion criteria:

• Teens between 12 and 16 years of age
• Confirmed diagnosis of schizophrenia
• Clinically stable with residual symptoms (PANSS ≥ 60 of and SANS ≥ 40)
• On an unchanged antipsychotic medication regimen for at least eight weeks prior to randomization into the study and expected to remain unchanged during the study

Major Exclusion criteria:

• At Screening meets the DSM criteria for major mental illness other than schizophrenia
• Schizophrenia resistant to antipsychotics
• Current substance abuse or positive urine illicit drug screening or history of substance dependence
• Use of depot antipsychotics in the past six months
• Body Mass Index> 35

If you would like to know more about the SND11 Study, please speak with your family doctor or psychiatrist, who may refer you to the local study team using the contact information below. They will be happy to give you more information about the study and answer any of your questions.

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