check_circleStudy Completed
Moderate depressive episodes (major depression)
Bayer Identifier:
20997
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Study to learn about relapse prevention of Hypericumextract (a drug based on the plant St. John wort) in outpatients suffering from moderate depressive episodes
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - 70 YearsTrial summary
Enrollment Goal
398Trial Dates
March 2009 - November 2011Phase
Phase 3Could I Receive a placebo
YesProducts
Laif® 900 (hypericum extract STW 3-VI, BAY98-7108)Accepts Healthy Volunteer
NoPrimary Outcome
- Relapse rateDefinition: 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.date_rangeTime Frame:24 weeks
Secondary Outcome
- Time between baseline and occurrence of relaps measured by: Total score of HAMD-17date_rangeTime Frame:24 weeks
- Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI)date_rangeTime Frame:24 weeks
- Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI)date_rangeTime Frame:24 weeks
- Global assessment of efficacy by investigators and patients% of investigators and patients, respectively, who rated the efficacy "very good" or "good", respectively.date_rangeTime Frame:12 and 24 weeks
- Safety and Tolerability: Number of Adverse Eventsdate_rangeTime Frame:36 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2