Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Steigerwald Arzneimittelwerk GmbH
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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
Clareo Health | Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes
