Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
- Conditions
- Nervous Restlessness
- Registration Number
- NCT02651922
- Lead Sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Brief Summary
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction.
- Detailed Description
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction. Data were collected in collaboration with 22 physicians in Germany.
The study was designed as a one armed non-interventional study. Patients had to suffer from nervous restlessness in order to be eligible for study documentation. Participants agreed to a medical treatment with PASCOFLAIR® of 12 weeks. In this context, documented patients could take PASCOFLAIR® at the first time or could have started within the past three months before the initial visit. Furthermore, documented patients had to be older than 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent. The patient must not be an alcoholic, must not be drug dependent and have no other types of addiction. Patients who were pregnant or breast-feeding were not eligible for study participation. Furthermore, patients showing hypersensitivity against passionflower extract or against other components of the medication were excluded. The signed declaration of consent of participating patients is available.
The treatment of affected patients may not be documented, if a redemption (written or spoken) of the declaration of consent is existing or the patient takes Benzodiazepines.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- patients suffering from nervous restlessness
- Age < 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent
- alcoholics, drug pending, addictive disorder
- pregnancy or lactating
- patients showing hypersensitivity against passionflower extract or against other components of the medication
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of Symptom Inner Restlessness (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
- Secondary Outcome Measures
Name Time Method Tolerability Assess Using a 5 Point Scale Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline) Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)
Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline) EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).
Change of Symptom Fear (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of Symptom Transpiration (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline ) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of Symptom Sleep Disturbance (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of Symptom Exhaustion (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of Symptom Trembling (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of BDEPQ (Benzodiazepine Dependence Questionnaire) Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline) The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month.
BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence).Change of Symptom Lack of Concentration (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of Symptom Nausea (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of Symptom Palpation (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"
Change of RS-13 (Resilience Questionnaire) (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).
Change of EQ-5D VAS Scores (Pre - Post) Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).