UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024424 |
|---|---|
| Receipt number | R000028107 |
| Scientific Title | An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2016/10/15 21:26:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Acronym
An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Scientific Title
An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Scientific Title:Acronym
An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Region
| Japan |
Condition
Condition
adolescent depression
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the adolescent patients with depression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: Changes from baseline in CDRS-R at 4-weeks ]
Key secondary outcomes
Depression Self-Rating Scale for Children (DSRS-C) Japenese Version [ Time Frame: Changes from baseline in DSRS-C at 4-weeks ]
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
| Medicine |
Interventions/Control_1
Tipepidine Hibenzate (30mg/day, 4weeks)
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
| 10 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Depressive Episode for ICD-10 criteria.
2.Patients are treated with antidepressants (SSRI ; Fluvoxamine, Paroxetine, Sertraline, Escitalopram, SNRI ; Milnacipran, Duloxetine, NaSSa; Mirtazapine), mood stabilizers (Lithium, Sodium Valproate, Carbamazepine, Lamotrigine), atypical antipsychotics (Risperidone, Olanzapine, Quetiapine, Perospirone, Aripiprazole, Blonanserin, Paliperidone) or not treated.
3.Patients are stable for 4-weeks for medication.
Key exclusion criteria
1.Patients with a previous hypersensitivity to Tipepidine Hibenzate.
2.Patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2.
3.Pregnant or breast-feeding women
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Chiba University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
TEL
043-222-7171
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Sasaki |
Organization
Chiba University Hospital
Division name
Department of Child Psychiatry
Zip code
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
TEL
043-222-7171
Homepage URL
https://clinicaltrials.gov/ct2/show/NCT01835847
sasaki@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
https://clinicaltrials.gov/ct2/show/NCT01835847
Org. issuing International ID_1
clinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院 (千葉県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/24833905?dopt=Abstract
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 18 | 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
| 2016 | Year | 10 | Month | 15 | Day |
Last modified on
| 2016 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028107
