St. John's Wort Extract LI 160 for the Treatment of Atypical Depression

Phase 3

Completed

• Conditions: Atypical Depression
• Interventions: Drug: Placebo; Drug: St. John's Wort extract

• Registration Number: NCT00861978
• Lead Sponsor: Cassella-med GmbH & Co. KG

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Status Verified: 2009-03
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-13
• Last Update Submitted: 2009-03-13
• Study First Posted: 2009-03-16
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months
• Female and male Caucasians aged 18 to 70 years
• At least one of HAMD-28 scale items 22-26 scores >1

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	St. John's Wort extract	-