Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01125579

Enrollment

115

Registered

2010-05-18

Start date

2008-03-31

Completion date

2008-11-30

Last updated

2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affective Disorders, Depression (Agitated), Nervousness, Restlessness

Keywords

nervousness, restlessness, depression, affective disorder

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results