An observational study in Nervousness, Restlessness and Depression (Agitated), sponsored by Pascoe Pharmazeutische Praeparate GmbH. Completed at 1 site in Germany. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Pascoe Pharmazeutische Praeparate GmbH · Observational
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.
231 studies on the registry are indexed under Psychomotor Agitation; 28 are open to participants now.
This study's enrollment of 115 is below the median of 138 across 31 observational studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Pascoe Pharmazeutische Praeparate GmbH is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 6 - 11 (extremes included) suffering from nervous restlessness and/or agitated depression according to ICD-10 F3 and DSM-IV "affective disorders"
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:
Children suffering from nervous restlessness, e.g. in agitated depression (ICD 10, F3 and DSM IV "affective disorders"), aged 6-12 years
Change in Parent Child Behaviour Checklist (CBCL/4-18)
Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire
Time frame: after 2 + 4 weeks´ treatment
Tolerability of NEURAPAS balance
kind, frequency, duration, outcome of ADR
Time frame: after 2 + 4 weeks
Change of 13 common symptoms of nervous restlessness
Questionnaire on 13 common symptoms of nervous restlessness in children
Time frame: 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
Time frame: after 2 + 4 weeks
The record gives a start of Mar 2008, a primary completion of Nov 2008 and a completion of Nov 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Pascoe Pharmazeutische Praeparate GmbH