Biomaterial Database

Dothiepin versus doxepin in major depression: results of a multicenter, placebo-controlled trial. Prothiaden Collaborative Study Group. 1994

J M Ferguson, and J Mendels, and N R Manowitz

Pharmacology Research Corporation, Salt Lake City, UT 84107-7591.

BACKGROUND The tricyclic antidepressant dothiepin is well established in Europe, but clinical experience with the drug in the United States is limited. METHODS In a 10-week, multicenter, randomized, double-blind, placebo-controlled study in the United States, the efficacy and tolerability of dothiepin and doxepin (both administered as a 150-mg nightly dose) were compared in 579 outpatients with major depression. RESULTS Patients in both active treatment groups showed significant improvements in depressive symptoms, associated anxiety, and sleep parameters compared with the placebo-treated group. The adverse effect profile of dothiepin was superior to that of doxepin, particularly with respect to drowsiness, weight gain, and increased appetite. CONCLUSIONS These results confirm that dothiepin is useful when a tricyclic agent is indicated for the treatment of depression.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D010352	Patient Dropouts	Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease.	Dropout, Patient,Dropouts, Patient,Patient Dropout
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
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
D004308	Dothiepin	A tricyclic antidepressant with some tranquilizing action.	Dosulepin,Dothiepin Hydrochloride,Prothiaden,Hydrochloride, Dothiepin
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
D004316	Doxepin	A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.	Apo-Doxepin,Aponal,Deptran,Desidox,Doneurin,Doxepia,Doxepin Hydrochloride,Doxepin Hydrochloride, Cis-Trans Isomer Mixture (approximately 1:5),Doxepin beta,Doxepin-RPh,Espadox,Mareen,Novo-Doxepin,Prudoxin,Quitaxon,Sinequan,Sinquan,Xepin,Zonalon,Apo Doxepin,ApoDoxepin,Doxepin RPh,Hydrochloride, Doxepin,Novo Doxepin
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