Org3770 Phase II (Org3770-1)

Phase 2

• Conditions: Depression or Depressive State

• Registration Number: JPRN-jRCT2080222778
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 240

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)

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total HAM-D score<br>Change in total HAM-D score (17 items) from before the start of treatment to completion (termination) of treatment

Secondary Outcome Measures

Name	Time	Method
1) HAM-D response rate<br>2) HAM-D remission rate<br>3) Clinical Global Impression (CGI) improvement rate<br>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<br>2) Percentage of subjects whose total HAM-D scores (17 items) are 7 or less as of the completion (termination) of treatment<br>3) Percentage of subjects for whom assessments of CGIs as of the completion (termination) of treatment is either Very much improved or Much improved