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Double-blind placebo-controlled multicenter evaluation of the efficacy and safety of nomifensine in depressed outpatients. 1984

B J Goldstein, and B Brauzer, and D Kentsmith, and S Rosenthal, and K D Charalampous

Outpatients with primary affective disorder-depression who scored at least 20 on the Hamilton Depression Rating Scale (HDRS) were randomly assigned to treatment for 1 month with nomifensine (100-200 mg/day) or placebo. Clinical laboratory and physical evaluations, including ECGs when feasible, revealed no clinically significant changes over the course of treatment. Nomifensine patients showed improvement compared to placebo on the HDRS total score endpoint analysis (p = .06) and the Cognitive Disturbance and Retardation factors (p less than or equal to .05). A better rate of improvement was seen with nomifensine on the Clinical Global Impressions severity of illness (p less than or equal to .05) and therapeutic index (p less than or equal to .05) components. No differences were seen between groups in the incidence of overall or specific side effects. Nomifensine thus appeared safe and superior to placebo on several key measures of depressive symptomatology in this multicenter study of depressed outpatients.

UI MeSH Term Description Entries
D007546 Isoquinolines A group of compounds with the heterocyclic ring structure of benzo(c)pyridine. The ring structure is characteristic of the group of opium alkaloids such as papaverine. (From Stedman, 25th ed)
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009627 Nomifensine An isoquinoline derivative that prevents dopamine reuptake into synaptosomes. The maleate was formerly used in the treatment of depression. It was withdrawn worldwide in 1986 due to the risk of acute hemolytic anemia with intravascular hemolysis resulting from its use. In some cases, renal failure also developed. (From Martindale, The Extra Pharmacopoeia, 30th ed, p266) Hoe-984,Linamiphen,Merital,Nomifensin,Nomifensine Maleate,Nomifensine Maleate (1:1),Hoe 984,Hoe984,Maleate, Nomifensine
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D011569 Psychiatric Status Rating Scales Standardized procedures utilizing rating scales or interview schedules carried out by health personnel for evaluating the degree of mental illness. Factor Construct Rating Scales (FCRS),Katz Adjustment Scales,Lorr's Inpatient Multidimensional Psychiatric Rating Scale,Wittenborn Scales,Edinburgh Postnatal Depression Scale,Mini International Neuropsychiatric Interview
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003866 Depressive Disorder An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent. Depression, Endogenous,Depression, Neurotic,Depression, Unipolar,Depressive Syndrome,Melancholia,Neurosis, Depressive,Unipolar Depression,Depressions, Endogenous,Depressions, Neurotic,Depressions, Unipolar,Depressive Disorders,Depressive Neuroses,Depressive Neurosis,Depressive Syndromes,Disorder, Depressive,Disorders, Depressive,Endogenous Depression,Endogenous Depressions,Melancholias,Neuroses, Depressive,Neurotic Depression,Neurotic Depressions,Syndrome, Depressive,Syndromes, Depressive,Unipolar Depressions

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