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

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder
• Intervention / Treatment: Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower); Drug: film-coated sugar-pill

Detailed 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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Siegen, NRW, Germany, D-57072
      • Dr. Urlea-Schoen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: film-coated sugar-pill; 3 x 2 tablets / day over 6 weeks
Experimental: Verum; Neurapas balance, film-coated tablet	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HAM-D 21	Visit 1 (Start of medication), Visit 2 (End of run-in phase), Visit 4 (after 2 weeks treatment), Visit 6 (after 4 weeks treatment), Visit 8 (End of Study)

Secondary Outcome Measures

Outcome Measure	Time Frame
Self-Rating Depression Scale (SDS)	V1, V2, V4, V6, V8
HAMILTON Anxiety Scale (HAM-A)	V2, V4, V6, V8
Clinical Global Impressions (CGI)	V2, V8
BULLINGER Quality of Life questionnaire (SF-36)	V2, V6, V8
Sleep questionnaire (SQ)	V2, V6, V8

Collaborators and Investigators

• Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Investigators: Principal Investigator: Ilie Urlea-Schoen, Dr med (RO)

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): July 1, 2002
• Study Completion (Actual): February 1, 2003

Study Registration Dates

• First Submitted: October 16, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Estimate): May 17, 2010
• Last Update Submitted That Met QC Criteria: May 14, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: depression; anxiety; Valerian; HAMA; HAMD 21; Hypericum; Passionflower; F32.0; F33.0
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: PSC 120/99