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NCT Number: NCT01125579

Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

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.

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Key information

Conditions

Nervousness Aberrant Motor Behavior in Dementia Affective Disorders Behavior Behavioral Symptoms Depression Depression (Agitated) Dyskinesias Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Restlessness Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

multiple German Paediatric Practices

Giessen, Hesse, 35394, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 18, 2010
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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