Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

NCT01125579 | Completed

• 1 other identifier: 162A07NPB
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Nervousness; Restlessness; Depression (Agitated); Affective Disorders

Keywords

nervousness; restlessness; depression; affective disorder

Outcome Measures

Primary Outcomes (1)

• Change in Parent Child Behaviour Checklist (CBCL/4-18)

  Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire

  after 2 + 4 weeks´ treatment

Secondary Outcomes (3)

• Tolerability of NEURAPAS balance

  after 2 + 4 weeks

• Change of 13 common symptoms of nervous restlessness

  after 2 + 4 weeks

• Change of the impact of the child´s complaints on daily family life (VAS)

  after 2 + 4 weeks

Study Arms (1)

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

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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"

You may not qualify if:

• Observational Criteria:
• age 6 - 11 (extremes included)
• nervous restlessness and/or
• agitated depression and/or
• affective disorders
• patients \<6 and \>12 years of age

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

Study Sites (1)

multiple German Paediatric Practices

Giessen, Hesse, 35394, Germany

Location

MeSH Terms

Conditions

Psychomotor Agitation; Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Anja Braschoss, MD

  Pascoe Pharmazeutische Praeparate GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 18, 2010
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 21, 2021

Record last verified: 2010-05

Locations

DE (1)