An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression

This study is currently recruiting participants.
Verified June 2013 by Chiba University
Sponsor:
Information provided by (Responsible Party):
Tsuyoshi Sasaki, Chiba University
ClinicalTrials.gov Identifier:
NCT01835847
First received: April 17, 2013
Last updated: June 30, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Depression
Adolescent
Drug: Tipepidine Hibenzate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tipepidine for Adolescent Depression

Resource links provided by NLM:


Further study details as provided by Chiba University:

Primary Outcome Measures:
  • 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):


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: April 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A single-arm study Drug: Tipepidine Hibenzate

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

[Inclusion Criteria]

  1. Depressive Episode for ICD-10 criteria.
  2. 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.
  3. Patients are stable for 4-weeks for medication.

[Exclusion Criteria]

  1. Patients with a previous hypersensitivity to Tipepidine Hibenzate.
  2. Patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2.
  3. Pregnant or breast-feeding women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835847

Contacts
Contact: Tsuyoshi Sasaki, MD +81-43-222-7171 sasaki@faculty.chiba-u.jp
Contact: Kenji Hashimoto, PhD +81-43-222-7171 hashimoto@faculty.chiba-u.jp

Locations
Japan
Department of Psychiatry, Chiba University School of Medicine Recruiting
Chiba, Chuo-ku, Japan, 260-8670
Contact: Tsuyoshi Sasaki, MD    +81-43-222-7171    sasaki@faculty.chiba-u.jp   
Contact: Kenji Hashimoto, PhD    +81-43-222-7171    hashimoto@faculty.chiba-u.jp   
Principal Investigator: Masaomi Iyo, MD,PhD         
Sponsors and Collaborators
Chiba University
  More Information

No publications provided

Responsible Party: Tsuyoshi Sasaki, Assistant Professor, Chiba University
ClinicalTrials.gov Identifier: NCT01835847     History of Changes
Other Study ID Numbers: G24062
Study First Received: April 17, 2013
Last Updated: June 30, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014