In adolescent schizophrenia, the symptoms start before the age of 17. In around 1 percent of schizophrenia patients, only the symptoms start at such a young age.
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
ClinicalTrials.gov (detailed description of SND11)
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.