Effect of Neurodoron in patients with nervous exhaustio

• Conditions: nervous exhaustion (neurasthenia); MedDRA version: 14.0Level: LLTClassification code 10029200Term: Nervous exhaustionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2010-024189-23-DE
• Lead Sponsor: Weleda AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-05
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified