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