Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

Affective Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125579
• Other study ID #: 162A07NPB
• Status: Completed
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: May 2010
• Source: Pascoe Pharmazeutische Praeparate GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorders
• Depression
• Depression (Agitated)
• Depressive Disorder
• Mood Disorders
• Nervousness
• Psychomotor Agitation
• Restlessness

Locations

Country	Name	City	State
Germany	multiple German Paediatric Practices	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Parent Child Behaviour Checklist (CBCL/4-18)	Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire	after 2 + 4 weeks´ treatment
Secondary	Tolerability of NEURAPAS balance	kind, frequency, duration, outcome of ADR	after 2 + 4 weeks
Secondary	Change of 13 common symptoms of nervous restlessness	Questionnaire on 13 common symptoms of nervous restlessness in children	after 2 + 4 weeks
Secondary	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