NCT04315597

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

Completed Phase 3 Last updated 19 March 2020

What this trial tests

Phase 3 trial testing Laif® 900, BAY98-7108 in Moderate Depressive Episodes (Major Depression) in 398 participants. Completed in 22 November 2011.

Timeline

3 March 2009

Primary endpoint
22 November 2011

22 November 2011

Quick facts

Lead sponsor	Bayer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	398
Start date	3 March 2009
Primary completion	22 November 2011
Estimated completion	22 November 2011

Drugs / interventions tested

• Laif® 900, BAY98-7108 — full drug profile →
• Placebo

Conditions studied

• Moderate Depressive Episodes (Major Depression) — all drugs for Moderate Depressive Episodes (Major Depression) →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 70, any sex, with Moderate Depressive Episodes (Major Depression). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
   Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200