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

Depressive Disorder Clinical Trial

Official title:
Phase III Placebo-controlled, Randomised, Single-centre, Double-blind Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation

Clinical Trial 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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00997490
Study type Interventional
Source Pascoe Pharmazeutische Praeparate GmbH
Contact
Status Terminated
Phase Phase 3
Start date January 2001
Completion date February 2003
View Details
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