An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression

Depression Clinical Trial

Official title:

Tipepidine for Adolescent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835847
• Other study ID #: G24062
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2013
• Last updated: May 22, 2014
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Chiba University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

[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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent
• Depression
• Depressive Disorder

Intervention

Drug:
• Tipepidine Hibenzate

Locations

Country	Name	City	State
Japan	Department of Psychiatry, Chiba University School of Medicine	Chiba	Chuo-ku

Sponsors (1)

Lead Sponsor	Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Sasaki T, Hashimoto K, Tachibana M, Kurata T, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, Kanahara N, Shiraishi T, Iyo M. Tipepidine in adolescent patients with depression: a 4 week, open-label, preliminary study. Neuropsychiatr Di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Rating Scale, Revised (CDRS-R)	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):	Changes from baseline in CDRS-R at 4-weeks	Yes
Secondary	Depression Self-Rating Scale for Children (DSRS-C) Japenese Version	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.	Changes from baseline in DSRS-C at 4-weeks	Yes