Trial | NCT00997490  Report issue

Title

Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)
Phase III Placebo-controlled, Randomised, Single-centre, Double-blind Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    neurapas ...

  • Study Participants

    67
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.
Study Started
Jan 31
2001
Primary Completion
Jul 31
2002
Study Completion
Feb 28
2003
Last Update
May 17
2010
Estimate

Drug Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)

3 x 2 tablets/day over 6 weeks

  • Other names: Neurapas balance, film-coated tablet

Drug film-coated sugar-pill

3 x 2 tablets / day over 6 weeks

Verum Experimental

Neurapas balance, film-coated tablet

Placebo Placebo Comparator

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.
No Results Posted