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

Depressive Disorder Clinical Trial

Official title:

Phase III Placebo-controlled, Randomised, Single-centre, Double-blind Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00997490
• Other study ID #: PSC 120/99
• Status: Terminated
• Phase: Phase 3
• First received: October 16, 2009
• Last updated: May 14, 2010
• Start date: January 2001
• Est. completion date: February 2003

Study information

• Verified date: May 2010
• Source: Pascoe Pharmazeutische Praeparate GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: February 2003
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)
3 x 2 tablets/day over 6 weeks
• film-coated sugar-pill
3 x 2 tablets / day over 6 weeks

Locations

Country	Name	City	State
Germany	Dr. Urlea-Schoen	Siegen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Self-Rating Depression Scale (SDS)		V1, V2, V4, V6, V8	No
Secondary	HAMILTON Anxiety Scale (HAM-A)		V2, V4, V6, V8	No
Secondary	Clinical Global Impressions (CGI)		V2, V8	No
Secondary	BULLINGER Quality of Life questionnaire (SF-36)		V2, V6, V8	No
Secondary	Sleep questionnaire (SQ)		V2, V6, V8	No