Status:
TERMINATED
Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)
Lead Sponsor:
Pascoe Pharmazeutische Praeparate GmbH
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 plac...
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, F3...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00997490
Start Date
January 1 2001
End Date
February 1 2003
Last Update
May 17 2010
Active Locations (1)
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1
Dr. Urlea-Schoen
Siegen, North Rhine-Westphalia, Germany, D-57072