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Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

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ClinicalTrials.gov Identifier: NCT01125579
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : May 19, 2010
Sponsor:
Information provided by:
Pascoe Pharmazeutische Praeparate GmbH

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
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 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 : March 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Group/Cohort
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



Primary Outcome Measures :
  1. Change in Parent Child Behaviour Checklist (CBCL/4-18) [ Time Frame: after 2 + 4 weeks´ treatment ]
    Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire


Secondary Outcome Measures :
  1. Tolerability of NEURAPAS balance [ Time Frame: after 2 + 4 weeks ]
    kind, frequency, duration, outcome of ADR

  2. Change of 13 common symptoms of nervous restlessness [ Time Frame: after 2 + 4 weeks ]
    Questionnaire on 13 common symptoms of nervous restlessness in children

  3. Change of the impact of the child´s complaints on daily family life (VAS) [ Time Frame: after 2 + 4 weeks ]
    Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Anja Braschoss, MD, Pascoe Pharmazeutische Preparate GmbH
ClinicalTrials.gov Identifier: NCT01125579     History of Changes
Other Study ID Numbers: 162A07NPB
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: May 19, 2010
Last Verified: May 2010

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

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