Sublingual Glycine vs. Placebo on Attentional Difficulties and Hyperactivity in Prepuberal Children

NCT02655276 | Completed

• 1 other identifier: Classroom FR03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Motor Activity; Attention Deficit; Stress, Psychological

Keywords

microencapsulated glycine; attentional performance; motoric activity; hyperactivity

Outcome Measures

Primary Outcomes (1)

• SKAMP-Combined rating scale in the classroom setting

  SKAMP-Combined rating performed at 25 minutes before and 0:50 h, 1,55 h, 2:50 h, 4:05 h, 5:50 h, 7:40 h and 8:35 h after first microencapsulated Glycine/ placebo intake in a laboratory classroom setting after a 3 week treatment period. The primary efficacy endpoint is the mean of the SKAMP-Combined score over all time points in the classroom setting.

  3 weeks

Secondary Outcomes (8)

• SKAMP-Attention subscale

  3 weeks

• SKAMP-Deportment subscale

  3 weeks

• Child Behaviour Checklist (CBCL)

  3 weeks

• Quality of life scores

  3 weeks

• Visual-Analogue-Scale of perceived parental stress

  3 weeks

Study Arms (2)

100 mg microencapsulated Glycine and then Placebo tablets

EXPERIMENTAL

100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the first three weeks and then Placebo t.i.d. from Biotiki® for the second three weeks.

Other: microencapsulated Glycine; Other: Placebo tablets

Placebo tablets and then 100 mg microencapsulated Glycine

EXPERIMENTAL

Placebo t.i.d. from Biotiki® for the first three weeks and then 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d. for the second three weeks.

Other: microencapsulated Glycine; Other: Placebo tablets

Interventions

microencapsulated Glycine OTHER

100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d.

100 mg microencapsulated Glycine and then Placebo tablets; Placebo tablets and then 100 mg microencapsulated Glycine

Placebo tablets OTHER

Placebo t.i.d. from Biotiki® in a crossover-design.

100 mg microencapsulated Glycine and then Placebo tablets; Placebo tablets and then 100 mg microencapsulated Glycine

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects aged 6-14 years with Tanner stages 0 to 3 and attentional and/or hyperactivity problems.
• Subjects with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, assent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the trial. Assent will be documented by the child´s signature on the consent form.
• Health Status: Subjects must not have clinically significant diseases or clinically significant abnormal laboratory values as assessed during medical history and physical exam.
• Subjects meeting minimum intelligence requirements: In the opinion of the investigator the subject must generally be functioning at age-appropriate levels academically, which should take into account any prior cognitive or academic testing (basic knowledge of reading, writing and calculating).
• Subject has an ADHD-RS-IV total score ≥18.
• Subjects already receiving behavioral therapies for HKS/ADHD or oppositional defiant disorder may continue to do sor during the course of the trial.

You may not qualify if:

• subjects with psychiatric disorders requiring current pharmacological treatment (e.g. major depression, psychosis)
• Subjects with psychiatric or somatic conditions that may contraindicate the trial or confound efficacy or safety assessments.
• Subjects with a history of drug abuse or current use of recreational drugs.
• History of hypersensitivity to microencapsulated Glycine or placebo.
• Subjects who are judged by the investigator as likely to be non-compliant with study procedures.
• Use of any investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Sponsors & Collaborators

• Eberhard Schulz: lead
• Biotiki: collaborator

Study Sites (1)

University Hospital

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

MeSH Terms

Conditions

Motor Activity; Attention Deficit Disorder with Hyperactivity; Stress, Psychological; Spasm

Condition Hierarchy (Ancestors)

Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eberhard Schulz, Prof. Dr.

  University Hospital Freiburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 14, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)