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

March 13, 2009 updated by: Cassella-med GmbH & Co. KG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
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
Other Names:
  • Jarsin
  • LI 160
Placebo Comparator: 1
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cassella-med GmbH & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (Estimate)

March 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2009

Last Update Submitted That Met QC Criteria

March 13, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160DE0838A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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