An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01835847
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : May 23, 2014
Information provided by (Responsible Party):
Tsuyoshi Sasaki, 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.

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)
Primary Purpose: Treatment
Official Title: Tipepidine for Adolescent Depression
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A single-arm study Drug: Tipepidine Hibenzate

Primary Outcome Measures :
  1. 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):

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

[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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01835847

Department of Psychiatry, Chiba University School of Medicine
Chiba, Chuo-ku, Japan, 260-8670
Sponsors and Collaborators
Chiba University

Publications of Results:
Responsible Party: Tsuyoshi Sasaki, Assistant Professor, Chiba University Identifier: NCT01835847     History of Changes
Other Study ID Numbers: G24062
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

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