UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013759 |
|---|---|
| Receipt number | R000016061 |
| Scientific Title | Interpersonal psychotherapy for non-psychotic emotionally disordered adolescents Study |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2015/08/28 13:19:13 |
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Basic information
Public title
Interpersonal psychotherapy for non-psychotic emotionally disordered adolescents Study
Acronym
IPT-NPEDs study
Scientific Title
Interpersonal psychotherapy for non-psychotic emotionally disordered adolescents Study
Scientific Title:Acronym
IPT-NPEDs study
Region
| Japan |
Condition
Condition
major depressive disorder
dysthymia
disruptive mood dysregulation disorder
other specified depressive disorder
other specified bipolar and related disorder
posttraumatic stress disorder
subthreshold posttraumatic stress disorder
anorexia nervosa
bulimia nervosa
binge-eating disorder
other specified feeding or eating disorder
somatic symptom disorder
other specified somatic symptom and related disorder
systemic exertion intolerance disease
non-suicidal self injury
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate interpersonal psychotherapy and treatment as usual for non-psychotic emotional disorders in Japanese adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Personal and Social Performance Scale
Key secondary outcomes
Hamilton Depression Rating Scale - Melancholia subscale
Hamilton Anxiety Rating Scale - Somatization subscale
Liebowitz Social Anxiety Scale for Children and Adolescents
Clinical Global Impression Scale - Severity (eating disorders only)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
interpersonal psychotherapy
Interventions/Control_2
treatment as usual
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
To be included in the study the participants (a) have to be between 12 and 18 years of age, (b) have non-psychotic emotional disorders.
Key exclusion criteria
Not fulfill criteria for schizophrenia spectrum and other psychotic disorders, ultra-high risk syndromes of schizophrenic psychoses, psychotic depression, bipolar I disorder, bipolar II disorder, bipolar at risk, autism spectrum disorder, intellectual disabilities, severe anorexia nervosa, severe obsessive compulsive disorder, substance use disorder, severe medical illness. Actively suicidal patients are excluded.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Ozaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
65 Tsurumaicho, Showaku, Nagoya
TEL
052-741-2111
ozaki-n@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Futoshi Suzuki |
Organization
Nagoya University Hospital
Division name
Dept. of Child and Adolescnet Psychiatry
Zip code
Address
65 Tsurumaicho, Showaku, Nagoya, Aichi
TEL
052-741-2111
Homepage URL
fsuzuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 15 | 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
| 2015 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 18 | Day |
Last modified on
| 2015 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016061
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
