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

Study Overview
=================
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.

Official Title
-----------------
Doubleblind, Randomized, Placebo-controlled, Multicenter Clinical Study to Investigate Relaps-prevention by Hypericumextract in Outpatients With Moderate Depressive Episodes (Major Depression)

Conditions
-----------------
Moderate Depressive Episodes (Major Depression)

Intervention / Treatment
-----------------
* Drug: Laif® 900, BAY98-7108
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypericum extract STW 3-VI (Laif® 900, BAY98-7108)<br> | Drug: Laif® 900, BAY98-7108<br>* 1 x daily, 1 tablet, 900 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 x daily, 1 tablet, 900 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between baseline and occurrence of relaps measured by: Total score of HAMD-17 |  | 24 weeks | 
| Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI) |  | 24 weeks | 
| Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI) |  | 24 weeks | 
| Global assessment of efficacy by investigators and patients | % of investigators and patients, respectively, who rated the efficacy very good or good, respectively. | 12 and 24 weeks | 
| Safety and Tolerability: Number of Adverse Events |  | 36 weeks |