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Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes

Primary Purpose

Moderate Depressive Episodes (Major Depression)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Laif® 900, BAY98-7108
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Depressive Episodes (Major Depression)

Eligibility Criteria

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

Inclusion Criteria:

Study Phase 1:

  • Age 18-70 years
  • Diagnosis according to DSM-IV-TR: 296.32: Outpatients with a mediocre depressive episode requiring treatment for recurrent major depression
  • At least 5 of the following symptoms must persist for 2 weeks, with at least one of the main symptoms:
  • Depressed mood (main symptom)
  • Loss of interest or pleasure (main symptom)
  • Significant weight loss without diet or weight gain
  • Increased sleep or insomnia
  • Psychomotor restlessness or slowing down
  • Excessive, inappropriate guilt or feelings of worthlessness on almost every day
  • Subjective or observable diminished ability to think and to decide
  • Fatigue and loss of energy
  • Suicidal thoughts and / or actions

Study Phase 2:

  • Phase 1 responders (= Phase 1 patients who have at least a 50% decrease in the HAMD-17 total score after 12 weeks of Laif® 900 therapy).

Exclusion Criteria: General (phase 1 and phase 2)

  • Unable to work and patients cared for according to the BtG (working group "Stay") and "Medical Measures")
  • Simple mourning reaction
  • Clinically relevant laboratory abnormalities due to severe organ and systemic diseases
  • Taking immunosuppressants (eg after organ transplants)
  • Taking oral contraceptives with low levels of hormones (estrogen ≤ 50 μg, micropillus)
  • Thyroid dysfunction (patients with non-euthyroid TSH levels)
  • Known intolerance to the test medication
  • Known photosensitivity
  • Diabetes mellitus type I and II requiring treatment
  • Unstable hypertension
  • Pregnancy or breastfeeding
  • Cancer and AIDS patients (HIV-positive)
  • Alcohol, drug or drug abuse in the last 6 months
  • Coadministration with coumarin-type anticoagulants
  • History of epilepsy
  • Melanoma
  • Specific psychotherapy in the last 2 months and during the clinical trial
  • Participation in a clinical trial within the last 30 days
  • Simultaneous participation in another clinical trial
  • Compliance and protocol management are not guaranteed by language problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Hypericum extract STW 3-VI (Laif® 900, BAY98-7108)

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Relapse rate
    Definition: Increase of the Hamilton rating scale for depression (HAMD)-17 total score in Phase 2 by > 5 points compared to Phase 2 baseline, if at the same time a total score of at least 12 is reached.

    Secondary Outcome Measures

    Time between baseline and occurrence of relaps measured by: Total score of HAMD-17
    Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI)
    Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI)
    Global assessment of efficacy by investigators and patients
    % of investigators and patients, respectively, who rated the efficacy "very good" or "good", respectively.
    Safety and Tolerability: Number of Adverse Events

    Full Information

    First Posted
    March 5, 2020
    Last Updated
    March 18, 2020
    Sponsor
    Bayer
    Collaborators
    Steigerwald Arzneimittelwerk GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04315597
    Brief Title
    Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes
    Official Title
    Doubleblind, Randomized, Placebo-controlled, Multicenter Clinical Study to Investigate Relaps-prevention by Hypericumextract in Outpatients With Moderate Depressive Episodes (Major Depression)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 3, 2009 (Actual)
    Primary Completion Date
    November 22, 2011 (Actual)
    Study Completion Date
    November 22, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer
    Collaborators
    Steigerwald Arzneimittelwerk GmbH

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The researchers in this trial want to learn more about the drug Laif® 900 in preventing the return of signs and symptoms of depressions (also called relapse) in patients suffering from moderate depression episodes. The study drug Laif® 900 is based on Hypericumextract made from the plant St. John wort. Patients will be accepted to take part in the study if they have 20-24 points on the Hamilton Depression Rating Scale (HAM-D) which is a questionnaire helping the doctor to rate the severity of the depression and includes questions on patient's mood, sleep difficulties, agitation, anxiety and weight loss. About 400 patients will be enrolled into the first part of the study and will be treated for 12 weeks with Laif® 900 capsule once daily. Only patients with an improved HAM-D score by 50% will stay in the study and continue with the second part of the study which will last for 24 weeks. In this second part of the study patients will receive either Laif® 900 capsule once daily or an inactive tablet (placebo). Neither the treating doctor nor the patient will know which patient receives the Laif® 900 or placebo. At the end of the study the researcher will assess the effectiveness of the study drug in prevention relapse of depression episodes and will also have more information on the safety of the study drug.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate Depressive Episodes (Major Depression)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    398 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypericum extract STW 3-VI (Laif® 900, BAY98-7108)
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Laif® 900, BAY98-7108
    Intervention Description
    1 x daily, 1 tablet, 900 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    1 x daily, 1 tablet, 900 mg
    Primary Outcome Measure Information:
    Title
    Relapse rate
    Description
    Definition: Increase of the Hamilton rating scale for depression (HAMD)-17 total score in Phase 2 by > 5 points compared to Phase 2 baseline, if at the same time a total score of at least 12 is reached.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Time between baseline and occurrence of relaps measured by: Total score of HAMD-17
    Time Frame
    24 weeks
    Title
    Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI)
    Time Frame
    24 weeks
    Title
    Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI)
    Time Frame
    24 weeks
    Title
    Global assessment of efficacy by investigators and patients
    Description
    % of investigators and patients, respectively, who rated the efficacy "very good" or "good", respectively.
    Time Frame
    12 and 24 weeks
    Title
    Safety and Tolerability: Number of Adverse Events
    Time Frame
    36 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
    Inclusion Criteria: Study Phase 1: Age 18-70 years Diagnosis according to DSM-IV-TR: 296.32: Outpatients with a mediocre depressive episode requiring treatment for recurrent major depression At least 5 of the following symptoms must persist for 2 weeks, with at least one of the main symptoms: Depressed mood (main symptom) Loss of interest or pleasure (main symptom) Significant weight loss without diet or weight gain Increased sleep or insomnia Psychomotor restlessness or slowing down Excessive, inappropriate guilt or feelings of worthlessness on almost every day Subjective or observable diminished ability to think and to decide Fatigue and loss of energy Suicidal thoughts and / or actions Study Phase 2: Phase 1 responders (= Phase 1 patients who have at least a 50% decrease in the HAMD-17 total score after 12 weeks of Laif® 900 therapy). Exclusion Criteria: General (phase 1 and phase 2) Unable to work and patients cared for according to the BtG (working group "Stay") and "Medical Measures") Simple mourning reaction Clinically relevant laboratory abnormalities due to severe organ and systemic diseases Taking immunosuppressants (eg after organ transplants) Taking oral contraceptives with low levels of hormones (estrogen ≤ 50 μg, micropillus) Thyroid dysfunction (patients with non-euthyroid TSH levels) Known intolerance to the test medication Known photosensitivity Diabetes mellitus type I and II requiring treatment Unstable hypertension Pregnancy or breastfeeding Cancer and AIDS patients (HIV-positive) Alcohol, drug or drug abuse in the last 6 months Coadministration with coumarin-type anticoagulants History of epilepsy Melanoma Specific psychotherapy in the last 2 months and during the clinical trial Participation in a clinical trial within the last 30 days Simultaneous participation in another clinical trial Compliance and protocol management are not guaranteed by language problems

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
    Links:
    URL
    https://clinicaltrials.bayer.com/
    Description
    Click here to find results for studies related to Bayer products.

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    Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes

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