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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children aged 6-12 | Children suffering from nervous restlessness, e.g. in agitated depression (ICD 10, F3 and DSM IV "affective disorders"), aged 6-12 years |
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| 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 |
| 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 |
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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:
Exclusion Criteria:
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Children aged 6 - 11 (extremes included) suffering from nervous restlessness and/or agitated depression according to ICD-10 F3 and DSM-IV "affective disorders"
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| Name | Affiliation | Role |
|---|---|---|
| Anja Braschoss, MD | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| multiple German Paediatric Practices | Giessen | Hesse | 35394 | Germany |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D003863 | Depression |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| 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 |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |