Status:
COMPLETED
Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes
Lead Sponsor:
Bayer
Collaborating Sponsors:
Steigerwald Arzneimittelwerk GmbH
Conditions:
Moderate Depressive Episodes (Major Depression)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 depres...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2011
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT04315597
Start Date
March 3 2009
End Date
November 22 2011
Last Update
March 19 2020
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