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

NCT00997490 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2010-05-17

No results posted yet for this study

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.

Conditions

  • Depressive Disorder

Interventions

DRUG

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

3 x 2 tablets/day over 6 weeks

DRUG

film-coated sugar-pill

3 x 2 tablets / day over 6 weeks

Sponsors & Collaborators

  • Pascoe Pharmazeutische Praeparate GmbH

    lead INDUSTRY

Principal Investigators

  • Ilie Urlea-Schoen, Dr med (RO)

  • Anja Braschoss, MD · Pascoe Pharmazeutische Praeparate GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2002-07-31
Completion
2003-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997490 on ClinicalTrials.gov