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Completed

NCT Number: NCT05477472

Low Dose St John's Wort for Depression

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.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

CERES Heilmittel AG

Kesswil, Thurgau, 8593, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

St John's Wort

Drug

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

Other names: CERES St John's Wort mother tincture

Primary outcomes

  1. Hamilton Depression Scale 17

    Time frame: Change at 6 weeks

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

Sponsors and collaborators

Lead sponsor

Ceres Heilmittel AG

Industry

Collaborators

  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2022
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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