Pooling 12 nomifensine studies for efficacy generalizability.
Twelve parallel group, randomized, double-blind studies of nomifensine's safety and efficacy in the treatment of depressed patients were combined into three pools according to common protocols. This approach permitted evaluation of 1) efficacy results for studies with moderate-sized pools of patients, 2) the degree to which efficacy was generalizable to depressed patients in the general population, and 3) the conditions under which pooled active vs. active (imipramine vs. nomifensine) studies could be regarded as pivotal in support of efficacy. Results showed that nomifensine's superiority over placebo was generalizable to patients with a wide range of characteristics, including age 60 years or older. An appropriate statistical profile of more pronounced nomifensine responders would include patients with a duration of present episode less than 4 months who are acutely depressed, exhibit more severe symptoms, and have been previously hospitalized or treated with other psychotropic medications. A comprehensive assessment and power analysis of the pooled active vs. active studies provided strong evidence for comparability of nomifensine and imipramine.
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000553:Ambulatory Care; D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization; D006801:Humans; D007099:Imipramine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009627:Nomifensine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010043:Outcome and Process Assessment, Health Care; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D011897:Random Allocation; D012107:Research Design; D013997:Time Factors
D007546:Isoquinolines; D010919:Placebos; D009627:Nomifensine; D007099:Imipramine