Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

Sponsor

Pascoe Pharmazeutische Praeparate GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01125579

Collaborator

(none)

115

Enrollment

Location

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nervousness Restlessness Depression (Agitated) Affective Disorders

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.

Study Design

Study Type:

Observational

Actual Enrollment :

115 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Change in Parent Child Behaviour Checklist (CBCL/4-18) [after 2 + 4 weeks´ treatment]
Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Due to the design as an Observational Study no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".