NCT00861978

Brief Summary

The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute treatment in mild to moderate depression with atypical features.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2002

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

Enrollment Period

1.9 years

First QC Date

March 13, 2009

Last Update Submit

March 13, 2009

Conditions

Atypical Depression

Keywords

mild to moderate depression with atypical features according to DSM-IV

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

2

EXPERIMENTAL
Drug: St. John's Wort extract

Interventions

St. John's Wort extractDRUG

Coated tablets (batch no. 02080277) containing 300 mg of St. John's Wort extract LI 160 (drug-extract ratio 3-6:1; extraction solvent: 80% Methanol in water; batch no. 02019073) administered orally twice daily (morning and evening) with some liquid for 8 weeks

Also known as: Jarsin, LI 160
2
PlaceboDRUG

Coated placebo tablets (batch no. 01010177) that were identical in shape, size, taste and color were administered orally twice daily (morning and evening) with some liquid for 8 weeks.

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months
  • Female and male Caucasians aged 18 to 70 years
  • At least one of HAMD-28 scale items 22-26 scores \>1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hypericum extract LI 160

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

December 1, 2002

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03