An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tipepidine for Adolescent Depression|
- Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: Changes from baseline in CDRS-R at 4-weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Contact: Tsuyoshi Sasaki, MDemail@example.com|
|Contact: Kenji Hashimoto, PhDfirstname.lastname@example.org|
|Department of Psychiatry, Chiba University School of Medicine||Recruiting|
|Chiba, Chuo-ku, Japan, 260-8670|
|Contact: Tsuyoshi Sasaki, MD +81-43-222-7171 email@example.com|
|Contact: Kenji Hashimoto, PhD +81-43-222-7171 firstname.lastname@example.org|
|Principal Investigator: Masaomi Iyo, MD,PhD|