Low Dose St John's Wort for Depression

NCT ID: NCT05477472

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-01-31

Brief 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.

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.

Conditions

Major Depression

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

St John's Wort

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

Intervention Type: DRUG

Other Intervention Names

CERES St John's Wort mother tincture

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Ceres Heilmittel AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Kalbermatten, cand. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

CERES Heilmittel AG

Kesswil, Thurgau, Switzerland

Countries

Switzerland

Other Identifiers

OS01

Identifier Type: -

Identifier Source: org_study_id