Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)
Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)
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.
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
 according to ICD 10, F32.0 and F33.0.

 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 study was conducted in accordance with the relevant requirements of the German Medicines
 Act (AMG), the Declaration of Helsinki (48th General Assembly, Sommerset West, Rep. of South
 Africa, October 1996) and ICH GCP guidelines.

 The improvement in symptoms of depression was assessed on the basis of the internationally
 established Hamilton Depression Scale 21 (primary efficacy criterion). 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 secondary efficacy criteria.
Inclusion Criteria:

 -  Depressive symptoms of mild intensity, as defined in the International Classification
 of Mental Disorders (ICD 10), codes F32.0 (mild depressive episode) and F33.0
 (recurrent depressive disorder, current episode mild)

 -  SDS Index between 51 and 59 (this criterion was declared null and void on 21.02.02 in
 the 2nd Amendment)

 -  HAM-D21 scores between 10 and 17

 -  Between 18 and 70 years of age

 -  Duration of depression: not less than 4 weeks and not longer than 2 years

 -  Signed informed consent to take part in the clinical study after verbal and written
 information.