Depression or Depressive State
Conditions
Interventions
investigational material(s)
Generic name etc : Org3770
INN of investigational material : Mirtazapine
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational m
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnostic criteria and main criteria for inclusion: Classified in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) as: 1) major depressive disorder, single episode (296.21 to 296.24) 2) major depressive disorder, recurrent (296.31 to 296.34) Inclusion criteria: 1) Patients with a total score of more than 18 on the Hamilton Depression Rating Scale (HAM-D) across 17 items before the start of treatment 2) Patients of either sex aged between 20 and 75 years at the time consent was given 3) Patients on an either inpatient or outpatient basis 4) Patients receiving an adequate explanation for the clinical trial's objectives, methods, significance and other relevant aspects and capable of providing written consent of their own free will etc.
Exclusion criteria
Exclusion criteria: 1) Patients with a cerebral organic disorder, schizophrenia and other psychotic disorders, bipolar disorder; 2) Classified in DSM-IV-TR as personality disorder or mental retardation; 3) Patients who are on medication with lithium carbonate, valproic acid, or carbamazepine; 4) Patients with a past history of hypersensitivity to any ingredient of mirtazapine; 5) Patients with a convulsive disease such as epilepsy; 6) Patients with an uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy); 7) Patients with a electroconvulsive therapy; 8) Patients who are on medication with monoamine oxidase inhibitor (past 14 days); 9) Patients who are pregnant or lactating, or who are suspected of being pregnant; 10) Patients who has high possibility of the suicide; 11) Current (past 6 months) substance abuse or dependence according to DSM-IV criteria; etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total HAM-D score Change in total HAM-D score (17 items) from before the start of treatment to completion (termination) of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) HAM-D response rate 2) HAM-D remission rate 3) Clinical Global Impression (CGI) improvement rate 1) Percentage of subjects whose total HAM-D scores (17 items) before the start of treatment are reduced by 50% or more as of the completion (termination) of treatment 2) Percentage of subjects whose total HAM-D scores (17 items) are 7 or less as of the completion (termination) of treatment 3) Percentage of subjects for whom assessments of CGIs as of the completion (termination) of treatment is either "Very much improved" or "Much improved" | — |
Outcome results
None listed