UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047405 |
|---|---|
| Receipt number | R000054062 |
| Scientific Title | Factors associated with treatment delay in patients with depression and schizophrenia: A mixed methods study comparing Austria and Japan |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2022/04/05 18:49:32 |
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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
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
hiroyuki_uchida@keio.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054062
