## Protocol Section
### Identification Module
**NCT ID:** NCT01125579

**Brief Title:** Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

**Official Title:** NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression

#### Organization Study ID Info
**ID:** 162A07NPB
#### Organization
**Class:** INDUSTRY
**Full Name:** Pascoe Pharmazeutische Praeparate GmbH
### Status Module
#### Completion Date
**Date:** 2008-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-21

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-11

**Type:** ACTUAL

#### Start Date
**Date:** 2008-03

**Status Verified Date:** 2010-05

#### Study First Post Date
**Date:** 2010-05-18
**Type:** ESTIMATED
**Study First Submit Date:** 2010-05-14
**Study First Submit QC Date:** 2010-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pascoe Pharmazeutische Praeparate GmbH

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Nervousness

- Restlessness

- Depression (Agitated)

- Affective Disorders

**Keywords:**

- nervousness

- restlessness

- depression

- affective disorder

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 115

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Children suffering from nervous restlessness, e.g. in agitated depression (ICD 10, F3 and DSM IV "affective disorders"), aged 6-12 years

**Label:** Children aged 6-12

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change in Parent Child Behaviour Checklist (CBCL/4-18)

**Time Frame:** after 2 + 4 weeks´ treatment

#### Secondary Outcomes

**Description:** kind, frequency, duration, outcome of ADR

**Measure:** Tolerability of NEURAPAS balance

**Time Frame:** after 2 + 4 weeks

**Description:** Questionnaire on 13 common symptoms of nervous restlessness in children

**Measure:** Change of 13 common symptoms of nervous restlessness

**Time Frame:** after 2 + 4 weeks

**Description:** Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life

**Measure:** Change of the impact of the child´s complaints on daily family life (VAS)

**Time Frame:** after 2 + 4 weeks

### Eligibility Module

**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

**Maximum Age:** 11 Years

**Minimum Age:** 6 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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"

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Giessen

**Country:** Germany

**Facility:** multiple German Paediatric Practices

**State:** Hessen

**Zip:** 35394

#### Overall Officials

**Official 1:**

**Affiliation:** Pascoe Pharmazeutische Praeparate GmbH

**Name:** Anja Braschoss, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000001523

- Term: Mental Disorders

- ID: D000020820

- Term: Dyskinesias

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000011596

- Term: Psychomotor Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000096762

- Term: Aberrant Motor Behavior in Dementia

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M21835

- Name: Mood Disorders

- Relevance: HIGH

- As Found: Affective Disorder

- ID: M14452

- Name: Psychomotor Agitation

- Relevance: HIGH

- As Found: Restlessness

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M14453

- Name: Psychomotor Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M3259

- Name: Aberrant Motor Behavior in Dementia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011595

- Term: Psychomotor Agitation

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

- ID: D000019964

- Term: Mood Disorders

### Misc Info Module

- Version Holder: 2024-05-24
