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

Bayer

Status and phase

Completed

Phase 3

Conditions

Moderate Depressive Episodes (Major Depression)

Treatments

Drug: Placebo

Drug: Laif® 900, BAY98-7108

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT04315597

20997

2008-001417-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

398 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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