| Disease | TO MODERATE DEPRESSION.
SYMPTOMS, ASSESSED WITH THE MELANCHOLIA SUBSCALE OF THE HAMILTON SCALE. THE PLACEBO AND WS 5570 GROUPS HAD COMPARABLE ADVERSE EVENTS. H. PERFORATUM EXTRACT WS 5570 WAS FOUND TO BE SAFE AND MORE EFFECTIVE THAN PLACEBO FOR THE TREATMENT OF MILD
TOTAL SCORE ON THE HAMILTON DEPRESSION SCALE AND SIGNIFICANTLY MORE PATIENTS WITH TREATMENT RESPONSE OR REMISSIIN. IT WAS MORE EFFECTIVE IN PATIENTS WITH HIGHER BASELINE HAMILTON SCORES AND LED TO GLOBAL REDUCTION OF DEPRESSION-RELATED CORE
CONDUCTED. THE DESIGN INCLUDED AN ADAPTIVE INTERIM ANALYSIS PERFORMAED AFTER RANDOM ASSIGNMENT OF 169 PATIENTS WITH OPTIONS FOR GROUP SIZE ADJUSTMENT OR EARLY TERMINATION. COMPARED TO PLACEBO, WS 5570 PRODUCED A SIGNIFICANLY GREATER REDUCTION IN
RESPONDER (PATIENTS WITH AT LEAST A 50% REDUCTION IN HAMILTON TOTAL SCORE) AND PATIENTS WITH REMISSIONS (PATIENTS WITH A TOTAL SCORE OF 6 OR LESS ON THE HAMILTON SCALE AT TREATMENT END) WERE CARRIED OUT, AND SUBSCALE/SUBGROUP ANALYSES WERE
DOUBLE-BLIND TREATMENT FOR 6 WEEKS. FOLLOW-UP VISITS WERE HELD AFTER 1,2,4, AND 6 WEEKS. THE PRIMARY OUTCOME MEASURE WAS THE CHANGE FROM BASELINE IN THE TOTAL SCORE ON THE 17-ITEM HAMILTON DEPRESSION RATING SCALE. IN ADDITIONAL, ANALYSES OF
ADULT OUTPATIENTS WITH MILD TO MODERATE MAJOR DEPRESSION (SINGLE OR RECURRENT EPISODE DSM-IV CRITERIA). AFTER A SINGLE-BLIND PLACEBO RUN-IN PHASE, THE PATIENTS WERE RANDOMLY ASSIGNED, 186 TO WS 5570 AND 189 TO PLACEBO, AFTER WHICH THEY RECEIVED
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL WITH 375 PATIENTS INVESTIGATED THE ANTIDPRESSANT EFFICACY AND SAFETY OF 300 MG T.I.D. OF HYDROALCOHOLIC HHYPERICUM PERFORATUM EXTRACT VS. 5570. THE STUDY PARTICIPANTS WERE MALE AND FEMALE |