Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)
Status:
Terminated
Trial end date:
2003-02-01
Target enrollment:
Participant gender:
Summary
The efficacy and tolerability of Neurapas® balance was compared against placebo in this
single-centre, controlled, double-blind study in patients with a mild depressive episode.
After a one-week placebo run-in phase to exclude placebo responders, patients were given the
study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily.
The improvement in symptoms of depression was assessed on the basis of the internationally
established Hamilton Depression Scale 21. The Self-Rating Depression Scale (SDS), the
Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life
questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ)
were used as further efficacy criteria.