Onset of schizophrenia mostly starts at early adulthood. There are limited options of medication for schizophrenia, including first generation antipsychotics like haloperidol and second generation antipsychotics like Risperidone or Olanzapine. Most time they can only help positive symptoms like hallucinations and delusions. Negative symptoms, like cognitive impairment and social withdrawn, in general are not responsive to the first and second generation antipsychotic medications.
- Screening phase (2 weeks)
- Enrichment run-in phase (4 weeks)
- Double-blind treatment phase (8 weeks)
- Open-label extension (52 weeks)
- Follow-up phase (2 weeks)
- Physical examinations
- Blood pressure and heart rate, EKG test
- Blood and urine test
- Male or female subjects who are between 18 and 55 years of age
- 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)
- 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 evaluations
- 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)
- Body Mass Index (BMI) between 17 and 35
- Subject has a negative routine urine illicit drug screening test
Major Exclusion criteria:
- At Screening meets the DSM criteria for major mental illness other than schizophrenia
- Subjects whose illness was resistant to antipsychotics according to prior treatments of two different antipsychotics of adequate dose
- Subjects who have been previously treated with clozapine or are currently receiving clozapine.
- Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to screening.
- The subject has previously received NaBen®
- 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
For more detailed information about the SND13 study, please see the US FDA clinical trial website below:
ClinicalTrials.gov (detailed description of SND13)
If you would like to know more about the SND13 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.