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Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

This study has been completed.
Sponsor:
Information provided by:
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01125579
First received: May 14, 2010
Last updated: May 18, 2010
Last verified: May 2010
History of Changes
  Purpose

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
Nervousness
Restlessness
Depression (Agitated)
Affective Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • Change in Parent Child Behaviour Checklist (CBCL/4-18) [ Time Frame: after 2 + 4 weeks´ treatment ] [ Designated as safety issue: No ]
    Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire


Secondary Outcome Measures:
  • Tolerability of NEURAPAS balance [ Time Frame: after 2 + 4 weeks ] [ Designated as safety issue: Yes ]
    kind, frequency, duration, outcome of ADR

  • Change of 13 common symptoms of nervous restlessness [ Time Frame: after 2 + 4 weeks ] [ Designated as safety issue: No ]
    Questionnaire on 13 common symptoms of nervous restlessness in children

  • Change of the impact of the child´s complaints on daily family life (VAS) [ Time Frame: after 2 + 4 weeks ] [ Designated as safety issue: No ]
    Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life


Enrollment: 115
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged 6 - 11 (extremes included) suffering from nervous restlessness and/or agitated depression according to ICD-10 F3 and DSM-IV "affective disorders"

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125579

Locations
Germany
multiple German Paediatric Practices
Giessen, Hessen, Germany, 35394
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Investigators
Study Director: Anja Braschoss, MD Pascoe Pharmazeutische Praeparate GmbH
  More Information

No publications provided

Responsible Party: Anja Braschoss, MD, Pascoe Pharmazeutische Preparate GmbH
ClinicalTrials.gov Identifier: NCT01125579     History of Changes
Other Study ID Numbers: 162A07NPB
Study First Received: May 14, 2010
Last Updated: May 18, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
nervousness
restlessness
depression
affective disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Psychomotor Agitation
Mood Disorders
Behavioral Symptoms
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013