Atypical Depression
Conditions
Keywords
mild to moderate depression with atypical features according to DSM-IV
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.
Interventions
DRUGSt. 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
DRUGPlacebo
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.
Sponsors
Cassella-med GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Outcome results
None listed