UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Epidemiological Research on Functioning Outcomes related to Major Depressive Disorder in Japan
Title of the study (Brief title)	Prospective Epidemiological Research on Functioning Outcomes related to Major Depressive Disorder in Japan (PERFORM-J)
Region	Japan

Condition
Condition	Major depressive disorder(MDD)
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the longitudinal pattern of cognitive function and depressive symptoms in MDD during episodes and following treatment over an observational period of 6 months.
Basic objectives2	Others
Basic objectives -Others	Assessment of the longitudinal pattern of cognitive function and depressive symptoms in MDD during episodes and following treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes from baseline in digit symbol substitution test (DSST) and Montgomery-Asberg depression scale (MADRS) after 2 and 6 months of treatment.
Key secondary outcomes	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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who meet all of the following criteria are included in this study. 1.Outpatients 2.Patients aged between 18 and 65 years at the time of informed consent 3.Patients with a current or new diagnosis of major depressive episode according to Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV-TR); diagnosis will be confirmed through the MINI International Neuropsychiatric Interview (MINI questionnaire) (Major Depressive Episode module). 4.Patients initiating a new antidepressant monotherapy (tricyclic or tetracyclic antidepressant, SSRI, SNRI, NaSSA) at the baseline visit (whether as first line or switch of antidepressant therapy) as decided by the investigator. 5.Patients who, in the opinion of the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements. 6.Patients who can sign and date an informed consent form prior to the conduction of the clinical research procedures. 7.Patients who are capable of reading and understanding questionnaire
Key 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
Target sample size	500

Research contact person
Name of lead principal investigator	Tomiki Sumiyoshi
Organization	National Center of Neurology and Psychiatry
Division name	Department of Clinical Epidemiology
Address	4-1-1 Ogawahigashimachi, Kodaira,Tokyo 187-8551, Japan
TEL	042-341-2711
Email	sumiyot@ncnp.go.jp

Public contact
Name of contact person	Kotaro Senuki
Organization	Sogo Rinsho Medefi Company Limited.
Division name	Business promotion department
Address	9F KDX Shinjuku building 3-2-7,Nishishinjuku,Shinjuku-ku,Tokyo
TEL	03-6901-6079
Homepage URL
Email	PERFORM-J@sogo-medefi.jp

Sponsor
Institute	Takeda Pharmaceutical Company Limited.
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 10 Month 06 Day
Last follow-up date	2018 Year 01 Month 10 Day
Date of closure to data entry	2018 Year 04 Month 02 Day
Date trial data considered complete	2018 Year 05 Month 10 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The prospective clinical study for Functioning Outcomes related to Major Depressive Disorder.

Management information
Registered date	2016 Year 10 Month 06 Day
Last modified on	2018 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028011