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Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

P

Pascoe Natural Healthcare

Status

Completed

Conditions

Nervousness
Depression (Agitated)
Restlessness
Affective Disorders

Study type

Observational

Funder types

Industry

Identifiers

NCT01125579
162A07NPB

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

  • patients <6 and >12 years of age

Trial design

115 participants in 1 patient group

Children aged 6-12
Description:
Children suffering from nervous restlessness, e.g. in agitated depression (ICD 10, F3 and DSM IV "affective disorders"), aged 6-12 years

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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