A Phase 3 interventional study of Laif® 900, BAY98-7108 and Placebo in Moderate Depressive Episodes (Major Depression), sponsored by Bayer. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 398 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Study Phase 1:
Study Phase 2:
Exclusion Criteria: General (phase 1 and phase 2)
Drug: Laif® 900, BAY98-7108
Drug: Placebo
1 x daily, 1 tablet, 900 mg
1 x daily, 1 tablet, 900 mg
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.
Time frame: 24 weeks
Time between baseline and occurrence of relaps measured by: Total score of HAMD-17
Time frame: 24 weeks
Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI)
Time frame: 24 weeks
Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI)
Time 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.
Time frame: 12 and 24 weeks
Safety and Tolerability: Number of Adverse Events
Time frame: 36 weeks
No study locations are listed for this record.
Plan to share: Undecided — Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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