Trial | NCT00861978  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    201
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.
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 Started
Dec 31
2002
Primary Completion
Nov 30
2004
Study Completion
Nov 30
2004
Last Update
Mar 16
2009
Estimate

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

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.

1 Placebo Comparator

2 Experimental

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
No Results Posted