UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062082 |
|---|---|
| Receipt number | R000071012 |
| Scientific Title | A Study of the Efficacy of Supportive Psychotherapy for Eating Disorders |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/06/25 23:55:34 |
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Basic information
Public title
A Study of the Efficacy of Supportive Psychotherapy for Eating Disorders
Acronym
Evaluation of the efficacy of supportive psychotherapy for eating disorders
Scientific Title
A Study of the Efficacy of Supportive Psychotherapy for Eating Disorders
Scientific Title:Acronym
Evaluation of the efficacy of supportive psychotherapy for eating disorders
Region
| Japan |
Condition
Condition
eating disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of supportive psychotherapy for eating disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CGI-I (Clinical Global Impressions-Improvement scale), Clinician Rating Scale at 8 weeks and the endpoint
Key secondary outcomes
At 8 weeks and the endpoint
Body weight
BMI (Body Mass Index)
Frequency of binge eating
Frequency of self-induced vomiting
Amount of laxatives
Eating Disorder Examination-Q
Eating Disorders Inventory-3
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
12-Session Supportive Psychotherapy (Based on the manual developed by the Supportive Psychotherapy Working Group of the Japanese Society for Eating Disorders)
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
| 15 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons diagnosed with anorexia nervosa based on DSM-5 criteria.
Body mass index (BMI) is greater than 14.0 at starting.
Duration of illness less than 4 years
Outpatients only
Persons who can understand the purpose and content of this trial and give voluntary written informed consent.
For participants who are minors, voluntary written informed consent must be obtained from their parent(s) or legal guardian(s).
Key exclusion criteria
Physical Crisis: (1) Body mass index (BMI) < 14 (2) Little or no food intake for more than 10 consecutive days (3) Rapid weight loss of more than 5 kg within one month (4) Severe electrolyte abnormalities
Psychological Crisis: (1) severe suicidal ideation; (2) self-injurious behavior; (3) violence toward others
Presence of clinically significant psychiatric comorbidities, including severe major depressive disorder, obsessive-compulsive disorder, and borderline (emotionally unstable) personality disorder.
Any patient considered unsuitable for study participation by the principal investigator at the participating study site.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshihihiko |
| Middle name | |
| Last name | Nagata |
Organization
Mental Clinic of Dr. Nagata in Nanba
Division name
Director
Zip code
542-0076
Address
SAN-EI-Midosuji Bldg. 3F, 3-5-8 Nanba, Chuo-Ku, Osaka
TEL
+81-6-6645-1455
clinic@nanba-nagata.com
Public contact
Name of contact person
| 1st name | Toshihihiko |
| Middle name | |
| Last name | Nagata |
Organization
Mental Clinic of Dr. Nagata in Nanba
Division name
Director
Zip code
542-0076
Address
SAN-EI-Midosuji Bldg. 3F, 3-5-8 Nanba, Chuo-Ku, Osaka
TEL
+81-6-6645-1455
Homepage URL
clinic@nanba-nagata.com
Sponsor or person
Institute
Mental Clinic of Dr. Nagata in Nanba
Institute
Department
Personal name
Funding Source
Organization
Mental Clinic of Dr. Nagata in Nanba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Japanese Association of Neuro-psychiatric Clinics
Address
Miyata Building 7F, 1-38-2 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
Tel
03-3320-1423
https://japc.or.jp/japc_contact/
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
北海道大学 大学院医学院健康管理医学教室
金沢大学附属病院 神経科精神科
信州大学医学部精神医学教室
東尾張病院
京都大学医学部附属病院精神科神経科
京都府立医科大学大学院医学研究科精神機能病態学
奈良県立医科大学 精神医学講座
大阪大学大学院連合小児発達学研究科 附属子どものこころの分子統御機構研究センター
大阪公立大学大学院医学研究科神経精神医学
兵庫医科大学精神科神経科学講座
福井大学 医学系部門 病態制御医学講座 精神医学
広島大学保健管理センター
山口大学医学部附属病院 精神科神経科
壱燈会 なんば・ながたメンタルクリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 27 | Day |
Last modified on
| 2026 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071012
