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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)
* Drug: film-coated sugar-pill


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Neurapas balance, film-coated tablet | Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)<br>* 3 x 2 tablets/day over 6 weeks<br>* Other names: Neurapas balance, film-coated tablet;|
| Placebo Comparator: Placebo<br> | Drug: film-coated sugar-pill<br>* 3 x 2 tablets / day over 6 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, HAMD 21, anxiety, HAMA, Hypericum, Valerian, Passionflower, F32.0, F33.0