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

Cassella-med

Status and phase: Completed; Phase 3

Conditions: Atypical Depression

Treatments: Drug: Placebo; Drug: St. John's Wort extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861978

160DE0838A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: St. John's Wort extract