An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression

Study Overview
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Brief Summary
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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.

Official Title
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Tipepidine for Adolescent Depression

Conditions
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Depression, Adolescent

Intervention / Treatment
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* Drug: Tipepidine Hibenzate


Participation Criteria
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Eligibility Criteria
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[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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A single-arm study<br> | Drug: Tipepidine Hibenzate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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): | Changes from baseline in CDRS-R at 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Changes from baseline in DSRS-C at 4-weeks |