Low Dose St John's Wort for Depression

Major Depression Clinical Trial

Official title:

Observational Study of the Efficacy and Tolerability of Low-dose Phytotherapy Using the Example of St John's Wort (Hypericum Perforatum)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05477472
• Other study ID #: OS01
• Status: Completed
• Start date: August 2005
• Est. completion date: January 2007

Study information

• Verified date: July 2022
• Source: Ceres Heilmittel AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study observes the routine use of low-dose St John's Wort herbal mother tincture in patients with major depression. It measures intensity of depression at the beginning of St Johns Wort and after 6 weeks and evaluates tolerability and compliance.

Description:

Herbal medicine is widely used, and high-quality evidence shows their efficacy and tolerability for specific disorders. Most of the studies, however, is conducted with standardized, relatively high dosed dry extract preparations, while other preparations such as tinctures are widely used as well. The aim of this observational study ist to document real-live use of the use of a low-dose herbal medicine preparation (a mother tincture) of St John's Wort (Hypericum perforatum), to compare depression intensity at the beginning and after 6 weeks of therapy using the Hamilton Depression Scale 17, and to evaluate tolerability and compliance. Finally, the results will be compared with results of randomized controlled trials examining high dosed dry extract preparations of St John's Wort for major depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of mild or moderate depression according to ICD-10 or DSM-IV
• new start of CERES St John's wort mother tincture

Exclusion Criteria:

• at the same time as St John's wort mother tincture started, other antidepressive therapy

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression

Intervention

Drug:
• St John's Wort
daily intake of CERES St John's Wort mother tincture. Dose according to the treating physician.

Locations

Country	Name	City	State
Switzerland	CERES Heilmittel AG	Kesswil	Thurgau

Sponsors (2)

Lead Sponsor	Collaborator
Ceres Heilmittel AG	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale 17	validated tool to measure depression intensity. Maximum score 51, minimum 0. Higher score means higher intensity of depressive symptoms.	Change at 6 weeks