Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)

• Status: Terminated
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Treatments: Antidepressive Agents

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.