NervousnessNCT01125579
Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
An observational study of Nervousness and Restlessness, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Nervousness, Restlessness, Depression (Agitated)
- Type of treatment
- Injection or infusion
- How many people
- 115 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
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"
Who may be able to join
None listed.
Who cannot join
- patients <6 and >12 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression
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.
Read the 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.
- Conditions
- Nervousness, Restlessness, Depression (Agitated), Affective Disorders
- Keywords
- nervousness, restlessness, depression, affective disorder
- Medical subject headings
- Psychomotor Agitation, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent Child Behaviour Checklist (CBCL/4-18)
Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire
Measured: after 2 + 4 weeks´ treatment
Secondary outcomes (3)
Tolerability of NEURAPAS balance
kind, frequency, duration, outcome of ADR
Measured: after 2 + 4 weeks
Change of 13 common symptoms of nervous restlessness
Questionnaire on 13 common symptoms of nervous restlessness in children
Measured: after 2 + 4 weeks
Change of the impact of the child´s complaints on daily family life (VAS)
Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life
Measured: after 2 + 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NervousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anja Braschoss, MD, Study director, Pascoe Pharmazeutische Praeparate GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125579
- Sponsor's protocol ID
- 162A07NPB
- Status last verified
- May 2010
- First submitted
- 14 May 2010
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression
- ClinicalTrials.gov ID
- NCT01125579
- Acronym / sponsor ID
- 162A07NPB
- Conditions
- Nervousness, Restlessness, Depression (Agitated), Affective Disorders
- Keywords
- nervousness, restlessness, depression, affective disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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"
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- patients <6 and >12 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Tolerability of NEURAPAS balance
Time frame: after 2 + 4 weeks
Change of 13 common symptoms of nervous restlessness
Time frame: after 2 + 4 weeks
Change of the impact of the child´s complaints on daily family life (VAS)
Time frame: after 2 + 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Braschoss, MD study director
Pascoe Pharmazeutische Praeparate GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nervousness and Restlessness, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Child Behaviour Checklist (CBCL/4-18) (time frame: after 2 + 4 weeks´ treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.