Low Dose St John's Wort for Depression

• Sponsor: Ceres Heilmittel AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05477472
• Collaborator: University of Zurich (Other)
• Enrollment: 55
• Location: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depression	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 Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Observational Study of the Efficacy and Tolerability of Low-dose Phytotherapy Using the Example of St John's Wort (Hypericum Perforatum)
• Actual Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

1. Hamilton Depression Scale 17 [Change at 6 weeks]

   validated tool to measure depression intensity. Maximum score 51, minimum 0. Higher score means higher intensity of depressive symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CERES Heilmittel AG	Kesswil	Thurgau	Switzerland	8593

Sponsors and Collaborators

• Ceres Heilmittel AG
• University of Zurich

Investigators

• Principal Investigator: Natalie Kalbermatten, cand. med., University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ceres Heilmittel AG
• ClinicalTrials.gov Identifier: NCT05477472
• Other Study ID Numbers: OS01
• First Posted: Jul 28, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Jul 28, 2022