Back to resultsAn Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Primary Purpose
Depression, Adolescent
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tipepidine Hibenzate
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
[Inclusion Criteria]
- Depressive Episode for ICD-10 criteria.
- 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.
- Patients are stable for 4-weeks for medication.
[Exclusion Criteria]
- Patients with a previous hypersensitivity to Tipepidine Hibenzate.
- Patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2.
- Pregnant or breast-feeding women
Sites / Locations
- Department of Psychiatry, Chiba University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A single-arm study
Arm Description
Outcomes
Primary Outcome Measures
Children's Depression Rating Scale, Revised (CDRS-R)
The CDRS-R is a brief rating scale based on a semi-structured interview with the child (or an adult informant who knows the child well). Designed for 6- to 12-year-olds, and successfully used with adolescents, it can be administered in just 15 to 20 minutes and easily scored in a few minutes more. The interviewer rates 17 symptom areas (including those that serve as DSM-IV criteria for a diagnosis of depression):
Secondary Outcome Measures
Depression Self-Rating Scale for Children (DSRS-C) Japenese Version
DSRS-C is easy to use and has a predictive value comparable with that of a psychiatric global rating of depressed appearance and history of depression obtained at interview. There was confirmation that the DSRS-C can tap an internal dimension of depression and that children are able to evaluate their feeling states.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01835847
Brief Title
An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Official Title
Tipepidine for Adolescent Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University
4. Oversight
5. Study Description
Brief Summary
Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of adolescent depression.
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.
If suggestion is obtained by this research about the effect on adolescent patients with depression of Tipepidine Hibenzate, it can contribute to development of the medical treatment of adolescent patients with depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A single-arm study
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tipepidine Hibenzate
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale, Revised (CDRS-R)
Description
The CDRS-R is a brief rating scale based on a semi-structured interview with the child (or an adult informant who knows the child well). Designed for 6- to 12-year-olds, and successfully used with adolescents, it can be administered in just 15 to 20 minutes and easily scored in a few minutes more. The interviewer rates 17 symptom areas (including those that serve as DSM-IV criteria for a diagnosis of depression):
Time Frame
Changes from baseline in CDRS-R at 4-weeks
Secondary Outcome Measure Information:
Title
Depression Self-Rating Scale for Children (DSRS-C) Japenese Version
Description
DSRS-C is easy to use and has a predictive value comparable with that of a psychiatric global rating of depressed appearance and history of depression obtained at interview. There was confirmation that the DSRS-C can tap an internal dimension of depression and that children are able to evaluate their feeling states.
Time Frame
Changes from baseline in DSRS-C at 4-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[Inclusion Criteria]
Depressive Episode for ICD-10 criteria.
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.
Patients are stable for 4-weeks for medication.
[Exclusion Criteria]
Patients with a previous hypersensitivity to Tipepidine Hibenzate.
Patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2.
Pregnant or breast-feeding women
Facility Information:
Facility Name
Department of Psychiatry, Chiba University School of Medicine
City
Chiba
State/Province
Chuo-ku
ZIP/Postal Code
260-8670
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24833905
Citation
Sasaki T, Hashimoto K, Tachibana M, Kurata T, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, Kanahara N, Shiraishi T, Iyo M. Tipepidine in adolescent patients with depression: a 4 week, open-label, preliminary study. Neuropsychiatr Dis Treat. 2014 May 5;10:719-22. doi: 10.2147/NDT.S63075. eCollection 2014. No abstract available.
Results Reference
result
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An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
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