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

Study Overview
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Brief Summary
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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.

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

Conditions
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Posttraumatic Stress Disorders

Intervention / Treatment
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* Drug: Ifenprodil Tartrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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[Inclusion Criteria] Diagnosis of PTSD based on DSM-IV-TR criteria. Score of 25 or higher on the IES-R. currently is an outpatient at Chiba University Hospital Department of Psychiatry or Child Psychiatry . currently receiving no medications for PTSD treatment with any of the following medications : 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) . Ages 13 - 18, male or female be stable on any medications for PTSD treatment they may be taking for the previous 4 weeks prior to enrollment in this study. Provision of written informed consent by patients and parents or guardian. must be able to swallow powdered medicine. [Exclusion Criteria] History of allergic reaction or hypersensitivity to Ifenprodil Tartrate. Patients who have not stopped bleeding after intracranial hemorrhage. Patients who have not been informed of having the disease at the time of informed consent. 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) . Somatic disorder which requires severe body management or severe meal management. 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. 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. pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study. participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention). planning change of treatment because of unstable neurological manifestations or somatic symptoms. History of suicidal ideation within the past year. Other clinically significant reasons for exclusion by investigators.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ifenprodil Tartrate<br>Oral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper) | Drug: Ifenprodil Tartrate<br> <br> |
| Placebo Comparator: Placebo<br>Oral Administration of Placebo (After breakfast, After supper) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Impact of Event Scale-Revised Japanese Version : IES-R-J | 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. | Changes from baseline in IES-R-J at 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trauma Symptom Checklist for Children Japanese Version : TSCC-J | 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. | Changes from baseline in TSCC-J at 4-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD/ifenprodil