Clinical trial NCT01125579: Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
Official title: NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nervousness
Restlessness
Depression (Agitated)
Affective Disorders
Keywords: nervousness
restlessness
depression
affective disorder
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 115
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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"

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.

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 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

Primary outcomes:
measure: Change in Parent Child Behaviour Checklist (CBCL/4-18)
timeFrame: after 2 + 4 weeks´ treatment
Secondary outcomes:
measure: Tolerability of NEURAPAS balance
timeFrame: after 2 + 4 weeks
measure: Change of 13 common symptoms of nervous restlessness
timeFrame: after 2 + 4 weeks
measure: Change of the impact of the child´s complaints on daily family life (VAS)
timeFrame: after 2 + 4 weeks
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: multiple German Paediatric Practices
state: Hessen
Study officials:
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Anja Braschoss, MD
role: STUDY_DIRECTOR
References: