Affective Disorders Clinical Trial
Official title:
NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression
NCT number | NCT01125579 |
Other study ID # | 162A07NPB |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2008 |
Est. completion date | November 2008 |
Verified date | May 2010 |
Source | Pascoe Pharmazeutische Praeparate GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 115 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 11 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | multiple German Paediatric Practices | Giessen | Hessen |
Lead Sponsor | Collaborator |
---|---|
Pascoe Pharmazeutische Praeparate GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Parent Child Behaviour Checklist (CBCL/4-18) | Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire | after 2 + 4 weeks´ treatment | |
Secondary | Tolerability of NEURAPAS balance | kind, frequency, duration, outcome of ADR | after 2 + 4 weeks | |
Secondary | Change of 13 common symptoms of nervous restlessness | Questionnaire on 13 common symptoms of nervous restlessness in children | after 2 + 4 weeks | |
Secondary | 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 | after 2 + 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03608449 -
Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System
|
N/A | |
Completed |
NCT02752295 -
Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
|
N/A | |
Completed |
NCT00163865 -
A Pilot Study of Boredom in a Community Sample of Adolescents and a Clinical Sample of Adolescents
|
N/A | |
Completed |
NCT03033420 -
Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials
|
N/A | |
Completed |
NCT03109028 -
Mental Health in Refugees and Asylum Seekers
|
N/A | |
Completed |
NCT03667729 -
The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia
|
N/A | |
Not yet recruiting |
NCT02095457 -
Routine Outcome Monitoring in Mental Health Outpatient
|
N/A | |
Completed |
NCT01815398 -
Cognitive Skills Training for Homeless Youth
|
N/A | |
Completed |
NCT02675257 -
Depression and Diabetes Control Trial
|
N/A | |
Completed |
NCT05379244 -
Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study
|
N/A | |
Completed |
NCT03335696 -
Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy
|
||
Completed |
NCT00288782 -
PET Neuroimaging of [11C]Mirtazapine
|
Phase 4 | |
Completed |
NCT00199940 -
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness
|
Phase 4 | |
Recruiting |
NCT01182012 -
Reduction of Cardiovascular Risk in Severe Mental Illness
|
Phase 4 | |
Completed |
NCT00340379 -
Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
|
Phase 2/Phase 3 |