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

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ClinicalTrials.gov Identifier: NCT00861978
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : March 16, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Atypical Depression Drug: St. John's Wort extract Drug: Placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2002
Primary Completion Date : November 2004
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
More Information

ClinicalTrials.gov Identifier: NCT00861978     History of Changes
Other Study ID Numbers: 160DE0838A
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by Cassella-med GmbH & Co. KG:
mild to moderate depression with atypical features according to DSM-IV

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders