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

This study has been completed.
Sponsor:
Information provided by:
Cassella-med GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00861978
First received: March 13, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Cassella-med GmbH & Co. KG:

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
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:
  • St. John's Wort extract
  • Jarsin
  • LI 160

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00861978     History of Changes
Other Study ID Numbers: 160DE0838A
Study First Received: March 13, 2009
Last Updated: March 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 25, 2014