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

Not Applicable

• Conditions: Post Traumatic Stress Disorder (PTSD)

• Registration Number: JPRN-UMIN000011720
• Lead Sponsor: Department of Psychiatry, Chiba University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-11
• Study Completion: 2018-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

[Exclusion Criteria] 1) History of allergic reaction or hypersensitivity to Ifenprodil Tartrate. 2) Patients who have not stopped bleeding after intracranial hemorrhage. 3) Patients who have not been informed of having the disease at the time of informed consent. 4) Diagnosis of any of the following diseases based on the DSM-IV-TR criteria. Mental Retardation, Pervasive Developmental Disorders, Attention-Deficit / Hyperactivity Disorder, Schizophrenia and Other Psychotic Disorders, Delirium, Dementia, and Amnestic and Other Cognitive Disorders, Substance-Related Disorders (except Caffeine-Related Disorders, Nicotine-Related Disorders). 5) Somatic disorder which requires severe body management or severe meal management. 6) receiving treatment, with antidepressants, mood stabilizers, and atypical antipsychotics other than those of the inclusion criteria 4), within 4 weeks prior to enrollment in this study. 7) receiving treatment with the following N-methyl-D aspartate (NMDA) receptor antagonists: Ketamine hydrochloride, Amantadine hydrochloride, Memantine hydrochloride, dextromethorphan, Methadone) within 4 weeks prior to enrollment in this study. 8) pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study. 9) participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention). 10) planning change of treatment because of unstable neurological manifestations or somatic symptoms. 11) History of suicidal ideation within the past year. 12) Other clinically significant reasons for exclusion by investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure: Title:The Impact of Event Scale-Revised Japanese Version : IES-R-J Time Frame: Changes from baseline in IES-R-J at 4-weeks