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Completed

NCT Number: NCT01835847

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.

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Key information

Conditions

Depression Adolescent Behavior Behavioral Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, Chiba University School of Medicine

Chiba, Chuo-ku, 260-8670, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[Inclusion Criteria]

  • Depressive Episode for ICD-10 criteria.
  • 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.
  • Patients are stable for 4-weeks for medication.

[Exclusion Criteria]

  • Patients with a previous hypersensitivity to Tipepidine Hibenzate.
  • Patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2.
  • Pregnant or breast-feeding women

Treatment and study plan

Tipepidine Hibenzate

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chiba University

Other

Registry information

Official study title

Tipepidine for Adolescent Depression

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2013
Registry last updated
May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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