Prospective Epidemiological Research on Functioning Outcomes related to Major Depressive Disorder in Japa

Not Applicable

• Conditions: Major depressive disorder(MDD)

• Registration Number: JPRN-UMIN000024320
• Lead Sponsor: Takeda Pharmaceutical Company Limited.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-06
• Study Completion: 2018-01-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in this study. 1.Patients who have a concurrent diagnosis or past history of any of the following conditions: Schizophrenia or other psychotic disorders .Bipolar disorders .Dementia or any other neurodegenerative disease .Substance dependence, including alcohol and other drugs, excluding mild and moderate nicotine dependence. Severe nicotine dependence will be excluded. .Any psychiatric disorder due to a general medical condition or substances 2.Patients prescribed with more than 1 antidepressant on the day of the baseline visit (combination of 2 or more antidepressants) 3.Patients prescribed antipsychotic on the day of the baseline visit (augmentation of the antidepressant prescription with an antipsychotic) 4.Patients prescribed mood stabilizers on the day of the baseline visit (augmentation of the antidepressant prescription with a mood stabilizer) 5.Patients having current treatment with electroconvulsive therapy (ECT) or repeated transcranial magnetic stimulation (rTMS) 6.Pregnant women, women breast feeding at the start of the research 7.Patients presenting acute suicidality in the investigator's opinion 8.Patients currently enrolled in an interventional clinical research such as clinical trial 9.Member of the research personnel or their immediate families, or subordinates (or immediate family member of a subordinate) to any of the research personnel. 10.Patient who has previously been enrolled in this research 11.Patients who, in the opinion of the investigator, unlikely to comply with the protocol

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline in digit symbol substitution test (DSST) and Montgomery-Asberg depression scale (MADRS) after 2 and 6 months of treatment.

Secondary Outcome Measures

Name	Time	Method
The number of patients with cognitive dysfunction using multiple measures (DSST, Item 6 of MADRS and PDQ-D) and depressive symptoms (MADRS) in patients with MDD at baseline, after 2 and 6 months of treatment. The association between cognitive dysfunction and psychosocial function in patients with MDD at baseline, after 2 and 6 months of treatment. Comparison of quality of life and resource uses between MDD patients with different levels of cognitive dysfunction at baseline, after 2 and 6 months of treatment.