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

This study has been terminated.
(Clearly identifiable benefits 50% of patients included)
Sponsor:
Information provided by:
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT00997490
First received: October 16, 2009
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)
Drug: film-coated sugar-pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Placebo-controlled, Randomised, Single-centre, Double-blind Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation

Resource links provided by NLM:


Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • HAM-D 21 [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-Rating Depression Scale (SDS) [ Time Frame: V1, V2, V4, V6, V8 ] [ Designated as safety issue: No ]
  • HAMILTON Anxiety Scale (HAM-A) [ Time Frame: V2, V4, V6, V8 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions (CGI) [ Time Frame: V2, V8 ] [ Designated as safety issue: No ]
  • BULLINGER Quality of Life questionnaire (SF-36) [ Time Frame: V2, V6, V8 ] [ Designated as safety issue: No ]
  • Sleep questionnaire (SQ) [ Time Frame: V2, V6, V8 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: January 2001
Study Completion Date: February 2003
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Neurapas balance, film-coated tablet
Placebo Comparator: Placebo Drug: film-coated sugar-pill
3 x 2 tablets / day over 6 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997490

Locations
Germany
Dr. Urlea-Schoen
Siegen, NRW, Germany, D-57072
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Investigators
Principal Investigator: Ilie Urlea-Schoen, Dr med (RO)
Study Director: Anja Braschoss, MD Pascoe Pharmazeutische Praeparate GmbH
  More Information

No publications provided

Responsible Party: Anja Braschoss, Pascoe Pharmazeutische Preparate GmbH
ClinicalTrials.gov Identifier: NCT00997490     History of Changes
Other Study ID Numbers: PSC 120/99
Study First Received: October 16, 2009
Last Updated: May 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
depression
HAMD 21
anxiety
HAMA
Hypericum
Valerian
Passionflower
F32.0
F33.0

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014