An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression

Phase 2

Completed

• Conditions: Depression; Adolescent
• Interventions: Drug: Tipepidine Hibenzate

• Registration Number: NCT01835847
• Lead Sponsor: Chiba University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-19
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A single-arm study	Tipepidine Hibenzate	-

Primary Outcome Measures

Name	Time	Method
Children's Depression Rating Scale, Revised (CDRS-R)	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):

Secondary Outcome Measures

Name	Time	Method
Depression Self-Rating Scale for Children (DSRS-C) Japenese Version	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.

Trial Locations

Locations (1)

Department of Psychiatry, Chiba University School of Medicine; 🇯🇵 Chiba, Chuo-ku, Japan