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St. John's Wort Extract LI 160 for the Treatment of Atypical Depression

Primary Purpose

Atypical Depression

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
St. John's Wort extract
Placebo
Sponsored by
Cassella-med GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atypical Depression focused on measuring mild to moderate depression with atypical features according to DSM-IV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2009
    Last Updated
    March 13, 2009
    Sponsor
    Cassella-med GmbH & Co. KG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00861978
    Brief Title
    St. John's Wort Extract LI 160 for the Treatment of Atypical Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cassella-med GmbH & Co. KG

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    The general picture of depression is still that of the traditionally called endogenous type, which is also the form that was characterized extensively in clinical trials. Atypical depression with reversed vegetative signs, such as hyperphagia or hypersomnia, is traditionalla neglected, demonstrated by the fact that in the most widely used depression scales, such as the Hamilton Depression Scale, melancholic symptoms have a specific weight, while, by contrast, reversed vegetative signs are not included. This etablishes a tendency to underestimate the severity of atypical depression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atypical Depression
    Keywords
    mild to moderate depression with atypical features according to DSM-IV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    201 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Title
    2
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    St. John's Wort extract
    Other Intervention Name(s)
    Jarsin, LI 160
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Main Inclusion Criteria: 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

    12. IPD Sharing Statement

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    St. John's Wort Extract LI 160 for the Treatment of Atypical Depression

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