An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
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|ClinicalTrials.gov Identifier: NCT01835847|
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : May 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Adolescent||Drug: Tipepidine Hibenzate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tipepidine for Adolescent Depression|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||March 2014|
|Experimental: A single-arm study||Drug: Tipepidine Hibenzate|
- Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: Changes from baseline in CDRS-R at 4-weeks ]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):
- Depression Self-Rating Scale for Children (DSRS-C) Japenese Version [ Time Frame: Changes from baseline in DSRS-C at 4-weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835847
|Department of Psychiatry, Chiba University School of Medicine|
|Chiba, Chuo-ku, Japan, 260-8670|