UMIN-CTR Clinical Trial

Basic information
Public title	Factors associated with treatment delay in patients with depression and schizophrenia: A mixed methods study comparing Austria and Japan
Acronym	Factors associated with treatment delay in patients with depression and schizophrenia: A mixed methods study comparing Austria and Japan
Scientific Title	Factors associated with treatment delay in patients with depression and schizophrenia: A mixed methods study comparing Austria and Japan
Scientific Title:Acronym	Factors associated with treatment delay in patients with depression and schizophrenia: A mixed methods study comparing Austria and Japan
Region	Japan Europe

Condition
Condition	Major Depressive Disorder Schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify what factors are associated with the duration of untreated illness (DUI) after illness onset in patients with unipolar major depression and schizophrenia in Austria and Japan
Basic objectives2	Others
Basic objectives -Others	- Duration of untreated illness (DUI) - Stigma: Social Impact Scale
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	- Duration of untreated illness (DUI) - Stigma: Social Impact Scale
Key secondary outcomes	1. Patients - sociodemographic and clinical information - 25-item Resilience Scale - Three questions on religiosity - Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Non-Illness Version (FACIT-Sp Non-Illness) - WHOQOL-BREF - Japanese Adult Reading Test (JART) - Personal and Social Performance Scale (PSP) - Montgomery Asberg Depression Rating Scale (MADRS)[Major Depressive Disorder] or Positive and Negative Syndrome Scale (PANSS)[Schizophrenia] 2. Key person - sociodemographic and clinical information - 25-item Resilience Scale

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Diagnosis of major depressive disorder or schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) 2. Capacity to provide informed consent 3. 18 years of age or older 4. Within 2 years of the first visit to participating sites
Key exclusion criteria	1. History of organic mental disorder, intellectual disability, or epilepsy 2. Presence of unstable physical conditions 3. Significant suicidal risk, or other factors that raise safety concerns as judged by the patient's treating physician or study investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Uchida
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	+81.3.5363.3971
Email	hiroyuki_uchida@keio.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Uchida
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	+81.3.5363.3971
Homepage URL
Email	hiroyuki_uchida@keio.jp

Sponsor
Institute	Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Mochida pharmaceutical co. ltd, Pfizer health research foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Psychiatry, Psychotherapy and Psychosomatics, Medical University Innsbruck
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, Keio University School of Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	+81. 3. 5363. 3503
Email	med-rinri-jimu@adst.keio.ac.jp

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	2022 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 11 Month 08 Day
Date of IRB	2021 Year 10 Month 11 Day
Anticipated trial start date	2021 Year 11 Month 27 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Duration of untreated illness (DUI)

Management information
Registered date	2022 Year 04 Month 05 Day
Last modified on	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054062