An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression

NCT01835847 | Completed Phase 2

• 1 other identifier: G24062
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Depression Self-Rating Scale for Children (DSRS-C) Japenese Version

  Changes from baseline in DSRS-C at 4-weeks

Study Arms (1)

A single-arm study

EXPERIMENTAL

Drug: Tipepidine Hibenzate

Interventions

Tipepidine Hibenzate DRUG

A single-arm study

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a previous hypersensitivity to Tipepidine Hibenzate.
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Chiba University: lead

Study Sites (1)

Department of Psychiatry, Chiba University School of Medicine

Chiba, Chuo-ku, 260-8670, Japan

Location

Related 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 Dis Treat. 2014 May 5;10:719-22. doi: 10.2147/NDT.S63075. eCollection 2014. No abstract available.

  PMID: 24833905 RESULT

MeSH Terms

Conditions

Depression

Interventions

tipepidine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 19, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

JP (1)