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

October 16, 2009
May 14, 2010
January 2001
July 2002   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00997490 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depressive Disorder
  • 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
  • Drug: film-coated sugar-pill
    3 x 2 tablets / day over 6 weeks
  • Experimental: Verum
    Neurapas balance, film-coated tablet
    Intervention: Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)
  • Placebo Comparator: Placebo
    Intervention: Drug: film-coated sugar-pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
February 2003
July 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00997490
PSC 120/99
Yes
Anja Braschoss, Pascoe Pharmazeutische Preparate GmbH
Pascoe Pharmazeutische Praeparate GmbH
Not Provided
Principal Investigator: Ilie Urlea-Schoen, Dr med (RO)
Study Director: Anja Braschoss, MD Pascoe Pharmazeutische Praeparate GmbH
Pascoe Pharmazeutische Praeparate GmbH
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP