Efficacy and safety of Neurodoron in patients with nervous exhaustion – a randomized, double-blind, placebo-controlled clinical trial –

Phase 4

• Conditions: F48.0; Neurasthenia

• Registration Number: DRKS00003261
• Lead Sponsor: WELEDA AGBereich Medizin/Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-15
• Study Completion: 2012-09-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 204

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, characterized by either A.1 or A.2:
A.1 Persistent and distressing complaints of feelings of exhaustion after minor mental effort (such as performing or attempting to perform every-day tasks that do not require unusual mental effort),
A.2 Persistent and distressing complaints of feelings of fatigue and bodily weakness after minor physical effort
and B. at least one of the following symptoms:
feelings of muscular aches and pains, dizziness, tension headaches, sleep disturbance, inability to relax, irritability.
C. Inability to recover from A.1 or A.2 by normal periods of rest, relaxation or entertainment.
D. The duration of the disorder is at least 3 months.

Exclusion Criteria

1. Concurrent or previous participation in clinical trials with trial drugs or other treatments for nervous exhaustion

2. Known hypersensitivity against wheat starch

3. Organic disease responsible for exhaustion (e.g. known heart, kidney or liver disease, uncontrolled diabetes mellitus, infection, iron deficiency anaemia, hypothyreotic metabolic situation)

4. Neuro-psychiatric disease causing exhaustion (e.g. psychosis, schizophrenia, dementia)

5. Organic brain syndrome (e.g. postencephalitic syndrome, sequelae of traumatic brain injury)

6. Presumed major depression, defined by BDI-II (Beck Depression Inventory) =29

7. Presumed major panic disorder or generalised anxiety disorder defined by GAD-7-score =16

8. Concomitant medication interfering with IMP, e.g. other drugs for treatment of stress/exhaustion/burnout, antidepressants or benzodiazepines during the last 4 weeks, initiation of treatment with oral beta-adrenoreceptorblockers

9. Known alcohol or drug abuse or dependency

10. Placement in an institution due to official directive or judicial order

11. Pregnancy, lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Difference of symptom-sumscore between beginning and end of treatment after 6 weeks via questionnaire<br><br>2. Perceived Stress, comparison of the results measured by the Perceived Stress Questionnaire (PSQ) at the beginning of treatment and after 6 weeks of treatment<br><br>3. General health status, measured by SF-36 at the beginning of treatment and after 6 weeks.<br>