Low Dose St John's Wort for Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: St John's Wort

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Switzerland
  • Thurgau
    • Kesswil, Thurgau, Switzerland, 8593
      • CERES Heilmittel AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients of outpatient physicians which are used to the therapy of major depression with CERES St John's Wort mother tincture

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ceres Heilmittel AG
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Natalie Kalbermatten, cand. med., University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2005
• Primary Completion (ACTUAL): January 1, 2007
• Study Completion (ACTUAL): January 1, 2007

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (ACTUAL): July 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: OS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No