The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.
This is a two-part, multi-center, prospective, randomized, placebo-controlled, parallel-group study, in which adolescent subjects with schizophrenia will be enrolled. Overall, eligible subjects will be randomized in a pre-defined 1:1 ratio to NaBen® or placebo. This study will be conducted in two parts: In Part 1 (Phase IIb) of the study, 76 subjects (\~ 60% of the total planned subjects) will be randomized in a 1:1 ratio (NaBen® or placebo), of which 38 subjects will be randomized to the NaBen® group and 38 subjects to the placebo group. An interim analysis (IA) will be conducted after the randomization of the 76th subject in Part 1 of the study. The data will be analyzed after all enrolled subjects in Part 1 of the study complete Visit 5 (week 6) or are withdrawn from the study, whichever occurs first. The data from IA will be reviewed by an independent Data Safety and Monitoring Committee (DSMC) that will be responsible for the review of the data from the Part 1 (Phase IIb) of the study for both safety and the effectiveness. In Part 2 (Phase III) of the study, a total of 50 subjects will be randomized, of which 25 subjects will be randomized to the NaBen® group and 25 subjects to the placebo group. The final subject numbers in the study will depend on the sample size re-estimation after Part 1 of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Harmonex Neuroscience Research
Dothan, Alabama, United States
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 6 weeks of treatment
Time frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score from baseline after 6 weeks of treatment
Time frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Percentage of subjects with 20% or more reduction in Positive and Negative Syndrome Scale (PANSS) total score from baseline after six (6) weeks of treatment
Time frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Percent change in Positive and Negative Syndrome Scale (PANSS) sub-scales
Time frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Percent change in Scale for Assessment of Negative Symptoms (SANS) total scores
Time frame: Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Percent change in Scale for Assessment of Negative Symptoms (SANS) sub-scale scores
Time frame: Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Percent change from baseline in the PANSS total score after 6 weeks of treatment
Time frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
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