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| Sponsored by: |
Cassella-med GmbH & Co. KG |
|---|---|
| Information provided by: | Cassella-med GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00861978 |
Purpose
The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute treatment in mild to moderate depression with atypical features.
| Condition | Intervention | Phase |
|---|---|---|
|
Atypical Depression |
Drug: St. John's Wort extract Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Enrollment: | 201 |
| Study Start Date: | December 2002 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Placebo Comparator |
Drug: Placebo
Coated placebo tablets (batch no. 01010177) that were identical in shape, size, taste and color were administered orally twice daily (morning and evening) with some liquid for 8 weeks.
|
| 2: Experimental |
Drug: St. John's Wort extract
Coated tablets (batch no. 02080277) containing 300 mg of St. John's Wort extract LI 160 (drug-extract ratio 3-6:1; extraction solvent: 80% Methanol in water; batch no. 02019073) administered orally twice daily (morning and evening) with some liquid for 8 weeks
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The general picture of depression is still that of the traditionally called endogenous type, which is also the form that was characterized extensively in clinical trials. Atypical depression with reversed vegetative signs, such as hyperphagia or hypersomnia, is traditionalla neglected, demonstrated by the fact that in the most widely used depression scales, such as the Hamilton Depression Scale, melancholic symptoms have a specific weight, while, by contrast, reversed vegetative signs are not included. This etablishes a tendency to underestimate the severity of atypical depression.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 160DE0838A |
| Study First Received: | March 13, 2009 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00861978 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
mild to moderate depression with atypical features according to DSM-IV |
|
Depression Mental Disorders Mood Disorders |
Depressive Disorder St. John's Wort Behavioral Symptoms |
|
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |
