nervous exhaustion (neurasthenia) MedDRA version: 14.0 Level: LLT Classification code 10029200 Term: Nervous exhaustion System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Neurodoron
Pharmaceutical Form: Tablet
Other descriptive name: Aurum metallicum praeparatum Trituration D10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Weleda AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent 2. At least 18 years of age 3. Confirmed diagnosis of nervous exhaustion according to the definition for neurasthenia as laid down in the WHO-criteria for research Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity against wheat starch 2. Organic disease responsible for exhaustion 3. Neuro-psychiatric disease causing exhaustion 4. Presumed major depression, defined by BDI-II (Beck Depression Inventary) =29 5. Presumed major panic disorder or generalised anxiety disorder defined by GAD-7-score =16 6. Concomitant therapy interfering with IMP 7. Commitment to an institution because of official or judicial order 8. Pregnancy, lactation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tedium Measure according to Pines/Aronson/Kafry, time until onset of treatment effect noted by the patient (reduction of characteristic symptoms), number of patients showing improvement =50% (measured by means of sumscore), number of dropouts due to lack of efficacy, number of dropouts due to adverse events, number and type and characteristics of adverse and serious adverse events, type and frequency of clinically relevant laboratory changes compared to baseline ;Timepoint(s) of evaluation of this end point: Baseline, after 2 weeks and after 6 weeks of treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For demonstration of efficacy of Neurodoron the following primary endpoints are sequentially analysed: 1. Occurence and intensity of characteristic symptoms of nervous exhaustion, calculated as a sumscore 2. Perceived Stress, measured by the Perceived Stress Questionnaire 3. General health status, measured by short form health survey SF-36;Secondary Objective: 1. Clinically relevant reduction in exhaustion, measured by the Tedium Measure according to Pines/Aronson/Kafry 2. Time until onset of significant improvement as noted by the patient (reduction of characteristic symptoms) 3. Number of patients showing improvement of =50% (measured by means of sumscore) 4. Number of dropouts because of lack of efficacy and/or adverse events 5. Number, type and characeristics of adverse and serious adverse events 6. Changes in laboratory values compared to baseline ;Primary end point(s): Efficacy of treatment is sequentially analysed by reduction of characteristic exhaustion symptoms (sumscore), perceived stress (Perceived Stress Questionnaire according to Fliege et al.), general health status (SF-36) ;Timepoint(s) of evaluation of this end point: Baseline, after 2 weeks and after 6 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactClinical Research
Weleda AG
Outcome results
None listed