Sublingual Glycine vs. Placebo on Attentional Difficulties and Hyperactivity in Prepuberal Children
Condition: Motor Activity; Attention Deficit; Stress, Psychological
MeSH terms: Hyperkinesis; Stress, Psychological
Study type: Interventional

Summary: 
      This study is designed to investigate effects on attentional performance and motoric activity
      of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after
      treatment with t.i.d. sublingual doses over 3 weeks each.

      The primary objective of the study is to determine the effects on attentional performance and
      motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to
      placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low
      attentional performance and high motoric activity.

      A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance
      and high motoric activity will be enrolled in this study. The prepuberal status will be
      determined by Tanner stages ≤ 3.
    

Detailed description: 
      Trial Design:

      This study has a double-blind, randomized, two-period, cross-over design. The study
      population will be randomized equally to the sequence 1 (first 3 weeks microencapsulated
      Glycine, second 3 weeks placebo) or sequence 2 (first 3 weeks placebo, second 3 weeks
      microencapsulated Glycine). Study Agent/Placebo - Dosage and Route of Administration:

      Study Agent/Placebo will first be dispensed at Visit 2 (day 0). Treatment assignments will be
      made in accordance with the randomization. At each visit (Visit 2 and Visit 3), subjects will
      receive two blisters for the 3 following weeks. Only qualified personnel may dispense study
      Agent/Placebo.

      Investigational and reference treatment:

      100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) Placebo from Biotiki®

      Study design:

      This study will employ a double blind, randomized, placebo-controlled cross-over design.
      SKAMP raters and teachers will be blinded concerning the study Agent/Placebo.

      Planned Study Time Schedule:

      The study ends 10 weeks after enrollment of the last patient (total study end). Study
      duration for each patient is between 7 and 10 weeks (from inclusion) until the last visit
      (close-out visit).

      Statistics:

      Sample size calculation is based on the primary endpoint "mean of the SKAMP Combined score
      over all time points in the classroom setting". The study should have sufficient power to
      detect a difference between treatments if a moderate effect size (corresponding to Cohen's
      d=0.5) were present in parallel-group study in two independent patient groups. Assuming a
      correlation between measurements in the same patient of 0.6, this translates into an effect
      size of 0.56 in a cross-over trial comparing within patient measurements. With this effect
      size, 27 patients have to be included in the study, to achieve a power of 0.8 at a two-sided
      significance level of alpha=0.05. To account for a small number of drop-outs, 30 patients
      have to be randomized.

      Data analysis: The trial will be analyzed according to the intention-to-treat principle.
      Efficacy measures will be evaluated by linear mixed models for repeated measurements.

      Safety analyses will be performed for subjects who received at least one dose of
      microencapsulated Glycine/ placebo. Incidences of adverse events and of serious adverse
      events will be calculated.
    

Intervention name(s): microencapsulated Glycine; Placebo tablets
Intervention type(s): Other; Other
Intervention description(s): 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d.; Placebo t.i.d. from Biotiki® in a crossover-design.
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: microencapsulated glycine; attentional performance; motoric activity; hyperactivity