NCT05477472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
15.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

June 27, 2022

Last Update Submit

July 25, 2022

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

St John's WortDRUG

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

Also known as: CERES St John's Wort mother tincture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CERES Heilmittel AG

Kesswil, Thurgau, 8593, Switzerland

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Natalie Kalbermatten, cand. med.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 28, 2022

Study Start

August 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)