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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum

Neurapas balance, film-coated tablet

Group Type EXPERIMENTAL

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

Intervention Type DRUG

3 x 2 tablets/day over 6 weeks

Placebo

Group Type PLACEBO_COMPARATOR

film-coated sugar-pill

Intervention Type DRUG

3 x 2 tablets / day over 6 weeks

Interventions

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

3 x 2 tablets/day over 6 weeks

Intervention Type DRUG

film-coated sugar-pill

3 x 2 tablets / day over 6 weeks

Intervention Type DRUG

Other Intervention Names

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Neurapas balance, film-coated tablet

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No