Nervous Restlessness
Conditions
Keywords
Nervous restlessness, Pascoflair, Passiflora incarnata, Benzodiazepine
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.
Interventions
None listed
Sponsors
Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany
Pascoe Pharmazeutische Praeparate GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients suffering from nervous restlessness
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 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 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). |
| 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 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PASCOFLAIR Group (Verum) Patients who were treated with PASCOFLAIR | 154 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | due to exclusion criteria | 2 |
Baseline characteristics
| Characteristic | PASCOFLAIR Group (Verum) |
|---|---|
| Age, Continuous | 47.9 years STANDARD_DEVIATION 17.1 |
| Age, Customized <=18 years | 1 participants |
| Age, Customized >=65 years | 23 participants |
| Age, Customized Between 18 and 65 years | 128 participants |
| Age, Customized missing data | 2 participants |
| Region of Enrollment Germany | 154 participants |
| Sex/Gender, Customized Female | 115 participants |
| Sex/Gender, Customized Male | 38 participants |
| Sex/Gender, Customized missing data | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 154 |
| serious Total, serious adverse events | 0 / 154 |
Outcome results
Primary
Change of Symptom Inner Restlessness (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 146 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Inner Restlessness (Pre - Post) | improved | 137 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Inner Restlessness (Pre - Post) | unchanged | 3 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Inner Restlessness (Pre - Post) | detoriated | 6 participants |
Secondary
Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)
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).
Time frame: Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) | improved | 104 participants |
| PASCOFLAIR Group (Verum) | Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) | unchanged | 22 participants |
| PASCOFLAIR Group (Verum) | Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) | deterioreated | 7 participants |
Secondary
Change of BDEPQ (Benzodiazepine Dependence Questionnaire)
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).
Time frame: Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)
Population: For patient with less than 75% items answered the BDEPQ-Score was not calculated.~For only 132 patients Score was calculated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of BDEPQ (Benzodiazepine Dependence Questionnaire) | improved | 91 participants |
| PASCOFLAIR Group (Verum) | Change of BDEPQ (Benzodiazepine Dependence Questionnaire) | unchanged | 13 participants |
| PASCOFLAIR Group (Verum) | Change of BDEPQ (Benzodiazepine Dependence Questionnaire) | deteriorated | 28 participants |
Secondary
Change of EQ-5D VAS Scores (Pre - Post)
VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of EQ-5D VAS Scores (Pre - Post) | improved | 119 participants |
| PASCOFLAIR Group (Verum) | Change of EQ-5D VAS Scores (Pre - Post) | unchanged | 5 participants |
| PASCOFLAIR Group (Verum) | Change of EQ-5D VAS Scores (Pre - Post) | deteriorated | 11 participants |
Secondary
Change of RS-13 (Resilience Questionnaire) (Pre - Post)
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).
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of RS-13 (Resilience Questionnaire) (Pre - Post) | improved | 115 participants |
| PASCOFLAIR Group (Verum) | Change of RS-13 (Resilience Questionnaire) (Pre - Post) | unchanged | 3 participants |
| PASCOFLAIR Group (Verum) | Change of RS-13 (Resilience Questionnaire) (Pre - Post) | deteriorated | 14 participants |
Secondary
Change of Symptom Exhaustion (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 145 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Exhaustion (Pre - Post) | improved | 130 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Exhaustion (Pre - Post) | unchanged | 7 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Exhaustion (Pre - Post) | detoriorated | 8 participants |
Secondary
Change of Symptom Fear (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 133 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Fear (Pre - Post) | detoriorated | 10 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Fear (Pre - Post) | improved | 121 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Fear (Pre - Post) | unchanged | 6 participants |
Secondary
Change of Symptom Lack of Concentration (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 142 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Lack of Concentration (Pre - Post) | improved | 123 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Lack of Concentration (Pre - Post) | unchanged | 11 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Lack of Concentration (Pre - Post) | detoriorated | 8 participants |
Secondary
Change of Symptom Nausea (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 92 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Nausea (Pre - Post) | improved | 79 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Nausea (Pre - Post) | unchnaged | 7 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Nausea (Pre - Post) | detoriorated | 6 participants |
Secondary
Change of Symptom Palpation (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 130 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Palpation (Pre - Post) | improved | 117 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Palpation (Pre - Post) | unchanged | 9 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Palpation (Pre - Post) | deteriorated | 4 participants |
Secondary
Change of Symptom Sleep Disturbance (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 146 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Sleep Disturbance (Pre - Post) | improved | 131 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Sleep Disturbance (Pre - Post) | unchanged | 8 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Sleep Disturbance (Pre - Post) | deteriorated | 7 participants |
Secondary
Change of Symptom Transpiration (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 121 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Transpiration (Pre - Post) | improved | 106 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Transpiration (Pre - Post) | unchanged | 9 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Transpiration (Pre - Post) | detoriorated | 6 participants |
Secondary
Change of Symptom Trembling (Pre - Post)
Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)
Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 108 patients showed this symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Change of Symptom Trembling (Pre - Post) | improved | 91 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Trembling (Pre - Post) | unchanged | 8 participants |
| PASCOFLAIR Group (Verum) | Change of Symptom Trembling (Pre - Post) | deterioreated | 9 participants |
Secondary
Tolerability Assess Using a 5 Point Scale
Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)
Time frame: Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PASCOFLAIR Group (Verum) | Tolerability Assess Using a 5 Point Scale | satisfactory | 2 participants |
| PASCOFLAIR Group (Verum) | Tolerability Assess Using a 5 Point Scale | bad | 1 participants |
| PASCOFLAIR Group (Verum) | Tolerability Assess Using a 5 Point Scale | very bad | 1 participants |
| PASCOFLAIR Group (Verum) | Tolerability Assess Using a 5 Point Scale | very good | 109 participants |
| PASCOFLAIR Group (Verum) | Tolerability Assess Using a 5 Point Scale | good | 35 participants |