Biomaterial Database

Randomized, double-blind comparison of venlafaxine and fluoxetine in outpatients with major depression. 1998

J Costa e Silva

University of Rio de Janeiro, Brazil.

BACKGROUND This was an 8-week, multicenter, randomized, double-blind, parallel-group study of the efficacy and tolerability of venlafaxine and fluoxetine. METHODS Outpatients with DSM-III-R major depression, a minimum score of 20 on the 21-item Hamilton Rating Scale for Depression (HAM-D), and depressive symptoms for at least 1 month were eligible. Patients were randomly assigned to treatment with venlafaxine, 37.5 mg twice daily, or fluoxetine, 20 mg once daily. The dose could be increased to venlafaxine, 75 mg twice daily, or fluoxetine, 20 mg twice daily, after 3 weeks for a poor response. The primary efficacy variables were the final on-therapy scores on the HAM-D, Montgomery-Asberg Depression Rating Scale (MADRS), and Clinical Global Impressions Severity of Illness (CGI-S) and Improvement (CGI-I) scales. RESULTS Three hundred eighty-two patients were randomly assigned to therapy and included in the intent-to-treat analysis. Both venlafaxine and fluoxetine produced significant reductions from baseline to day 56 in mean HAM-D, MADRS, and CGI-S scores, but no significant differences were noted between groups. Among patients who increased their dose at 3 weeks, significantly (p < .05) more patients taking venlafaxine than taking fluoxetine had a CGI-I score of 1 (very much improved) at the final evaluation. The most frequent adverse events were nausea, headache, and dizziness with venlafaxine and nausea, headache, and insomnia with fluoxetine. CONCLUSIONS These results support the efficacy and tolerability of venlafaxine in comparison with fluoxetine for treating outpatients with major depression.

UI	MeSH Term	Description	Entries
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
D003511	Cyclohexanols	Monohydroxy derivatives of cyclohexanes that contain the general formula R-C6H11O. They have a camphorlike odor and are used in making soaps, insecticides, germicides, dry cleaning, and plasticizers.	Cyclohexanol
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
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004334	Drug Administration Schedule	Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.	Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D005473	Fluoxetine	The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.	Fluoxetin,Fluoxetine Hydrochloride,Lilly-110140,N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine,Prozac,Sarafem,Lilly 110140,Lilly110140
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069470	Venlafaxine Hydrochloride	A cyclohexanol and phenylethylamine derivative that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT.	1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)cyclohexanol HCl,Cyclohexanol, 1-(2-(dimethylamino)-1-(4-methoxyphenyl)ethyl)-, hydrochloride,Dobupal,Efexor,Effexor,Sila-Venlafaxine,Trevilor,Vandral,Venlafaxine,Wy 45030,Wy-45,030,Wy-45030,Hydrochloride, Venlafaxine,Sila Venlafaxine,Wy 45,030,Wy45,030,Wy45030
D000553	Ambulatory Care	Health care services provided to patients on an ambulatory basis, rather than by admission to a hospital or other health care facility. The services may be a part of a hospital, augmenting its inpatient services, or may be provided at a free-standing facility.	Outpatient Care,Outpatient Health Services,Clinic Visits,Health Services, Outpatient,Outpatient Services,Services, Outpatient Health,Urgent Care,Care, Ambulatory,Care, Outpatient,Care, Urgent,Cares, Urgent,Clinic Visit,Health Service, Outpatient,Outpatient Health Service,Outpatient Service,Service, Outpatient,Service, Outpatient Health,Services, Outpatient,Urgent Cares,Visit, Clinic,Visits, Clinic
D016896	Treatment Outcome	Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.	Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes