Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial

Phase 1

Completed

• Conditions: Posttraumatic Stress Disorders
• Interventions: Drug: Placebo; Drug: Ifenprodil Tartrate

• Registration Number: NCT01896388
• Lead Sponsor: Chiba University

Brief Summary

Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD. The purpose of this study is to confirm whether ifenprodil tartrate is effective in the treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these patients, this study contributes to the development of novel therapeutic drugs for PTSD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Study Start: 2014-01-21
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-17
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral Administration of Placebo (After breakfast, After supper)
Ifenprodil Tartrate	Ifenprodil Tartrate	Oral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper)

Primary Outcome Measures

Name	Time	Method
The Impact of Event Scale-Revised Japanese Version : IES-R-J	Changes from baseline in IES-R-J at 4-weeks	Evidence includes retest reliability and internal consistency of the IES-R-J. Posttraumatic stress disorder (PTSD) and partial PTSD cases indicated significantly higher scores than non-PTSD cases. The IES-R-J can be a useful self-rating diagnostic instrument particularly for survivors with PTSD symptoms as a clinical concern (PTSD + partial PTSD) by using a 24/25 cutoff in total score. The IES-R-J can be used as a validated instrument in future international comparative research.

Secondary Outcome Measures

Name	Time	Method
Trauma Symptom Checklist for Children Japanese Version : TSCC-J	Changes from baseline in TSCC-J at 4-weeks	The TSCC allows you to measure posttraumatic stress and related psychological symptomatology in children ages 8-16 years who have experienced traumatic events, such as physical or sexual abuse, major loss, or natural disasters, or who have been a witness to violence.; The 54-item TSCC includes two validity scales (Underresponse and Hyperresponse), six clinical scales (Anxiety, Depression, Anger, Posttraumatic Stress, Dissociation, and Sexual Concerns), and eight critical items. Profile Forms allow for conversion of raw scores to age- and sex-appropriate T scores and enable you to graph the results.; The TSCC-A, an alternate 44-item version of the measure, makes no reference to sexual issues.

Trial Locations

Locations (1)

Department of Psychiatry, Chiba University School of Medicine Chiba, Chuo-ku, Japan 260-8670; 🇯🇵 Chiba, Chuo-ku, Japan