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

NCT00997490 | Terminated Phase 3 DMC

• 1 other identifier: PSC 120/99
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

depression; HAMD 21; anxiety; HAMA; Hypericum; Valerian; Passionflower; F32.0; F33.0

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Verum

EXPERIMENTAL

Neurapas balance, film-coated tablet

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

Placebo

PLACEBO COMPARATOR

Drug: film-coated sugar-pill

Interventions

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

3 x 2 tablets/day over 6 weeks

Also known as: Neurapas balance, film-coated tablet

Verum

film-coated sugar-pill DRUG

3 x 2 tablets / day over 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

Study Sites (1)

Dr. Urlea-Schoen

Siegen, North Rhine-Westphalia, D-57072, Germany

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Anxiety Disorders

Interventions

Valeriana extract

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ilie Urlea-Schoen, Dr med (RO)

  PRINCIPAL INVESTIGATOR

• Anja Braschoss, MD

  Pascoe Pharmazeutische Praeparate GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 19, 2009
• Study Start: January 1, 2001
• Primary Completion: July 1, 2002
• Study Completion: February 1, 2003
• Last Updated: May 17, 2010

Record last verified: 2010-05

Locations

DE (1)