BACKGROUND: The @entity1037 / @entity905 combination has demonstrated effectiveness in @entity13217 ( @entity13217 ). Although this combination is being used by prescribers, this is the first study to examine long-term use. Long-term efficacy and safety were therefore investigated in a group of @entity1 with @entity308 ( @entity308 ) with and without @entity13217 . METHOD: 560 @entity1 who met DSM-IV diagnostic criteria for @entity308 were enrolled in this 76-week, open-label study (Feb. 2000-July 2002). The Montgomery-Asberg Depression Rating Scale (MADRS) total score was the primary efficacy measure. Safety was assessed via adverse events, vital signs, laboratory analytes, electrocardiography, and extrapyramidal symptom measures. RESULTS: MADRS mean total scores decreased 7 points from baseline (31.6 [N = 552]) at 1/2 week of treatment, 11 points at 1 week of treatment, and 18 points at 8 weeks of treatment. This effect was maintained to endpoint with a mean decrease of 22 points at 76 weeks. Response and remission rates for the total sample were high (62% and 56%, respectively), and the relapse rate was low (15%). Response, remission, and relapse rates for @entity13217 @entity1 (N = 145) were 53%, 44%, and 25%, respectively. The most frequently reported adverse events were @entity2147 , @entity1017 , @entity2133 , increased appetite, and @entity10 . At endpoint, there were no clinically meaningful changes in vital signs, laboratory analytes, or electrocardiography. There were no significant increases on any measure of extrapyramidal symptoms. CONCLUSIONS: The @entity1037 / @entity905 combination showed rapid, robust, and sustained improvement in @entity308 in @entity1 with @entity308 , including @entity1 with @entity13217 . The long-term safety profile of the combination was similar to that of its component monotherapies.

Long-term antidepressant efficacy and safety of XXXX / @entity905 combination: a 76-week open-label study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity308 :: ('MESH:D003866', 'Disease') :: ['MDD', 'depressive symptoms', 'major depressive disorder'] @entity905 :: ('MESH:D005473', 'Chemical') :: ['fluoxetine'] @entity2133 :: ('MESH:D014987', 'Disease') :: ['dry mouth'] @entity2147 :: ('MESH:D006970', 'Disease') :: ['somnolence'] @entity13217 :: ('MESH:D061218', 'Disease') :: ['TRD', 'treatment-resistant depression'] @entity1017 :: ('MESH:D015430', 'Disease') :: ['weight gain'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity1037 :: ('MESH:C076029', 'Chemical') :: ['olanzapine']
@entity1037 :: (MESH:C076029,Chemical) :: ['olanzapine']
