Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

Study Overview
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Brief Summary
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Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.

Detailed Description
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Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Patients and methods: A prospective, non-interventional, non-randomized, observational study conducted in German pediatric practices. Each patient is treated with NPB. No placebo group is established. As subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS) is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.

Official Title
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NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression

Conditions
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Nervousness, Restlessness, Depression (Agitated), Affective Disorders

Participation Criteria
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Eligibility Criteria
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Due to the design as an Observational Study no inclusion or exclusion criteria are named. The included patient group is described under Cohort / Group. Observational Criteria: age 6 - 11 (extremes included) nervous restlessness and/or agitated depression and/or affective disorders Exclusion Criteria: patients <6 and >12 years of age

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children aged 6-12<br>Children suffering from nervous restlessness, e.g. in agitated depression (ICD 10, F3 and DSM IV affective disorders), aged 6-12 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parent Child Behaviour Checklist (CBCL/4-18) | Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire | after 2 + 4 weeks´ treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of NEURAPAS balance | kind, frequency, duration, outcome of ADR | after 2 + 4 weeks | 
| Change of 13 common symptoms of nervous restlessness | Questionnaire on 13 common symptoms of nervous restlessness in children | after 2 + 4 weeks | 
| Change of the impact of the child´s complaints on daily family life (VAS) | Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life | after 2 + 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nervousness, restlessness, depression, affective disorder