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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024424
Receipt No. 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

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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
Email 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
Email sasaki@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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