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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ifenprodil Tartrate | Active Comparator | Oral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper) |
|
| Placebo | Placebo Comparator | Oral Administration of Placebo (After breakfast, After supper) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ifenprodil Tartrate | Drug |
| ||
| Placebo |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
[Inclusion Criteria]
[Exclusion Criteria]
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| Name | Affiliation | Role |
|---|---|---|
| Masaomi Iyo, MD,PhD | Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine | Study Chair |
| Nobuhisa Kanahara, MD,PhD | Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental Health | Study Director |
| Tasuku Hashimoto, MD.PhD | Department of Psychiatry, Chiba University Graduate School of Medicine | Study Director |
| Akihiro Shiina, MD,PhD | Department of Child Psychiatry, Chiba University Hospital | Study Director |
| Tomihisa Niitsu, MD,PhD | Research Center for Child Mental Development, Chiba University Graduate School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Chiba University School of Medicine Chiba, Chuo-ku, Japan 260-8670 | Chiba | Chuo-ku | 260-8670 | Japan |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C010739 | ifenprodil |
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| Changes from baseline in TSCC-J at 4-weeks |
| Changes from baseline in CDRS-R at 4-weeks |
| Depression Self-Rating Scale for Children Japanese Version: DSRS-C-J | DSRS-C-J 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-J can tap an internal dimension of depression and that children are able to evaluate their feeling states. | Changes from baseline in DSRS-C-J at 4-weeks |
| Clinical Global Impressions-Post Traumatic Stress Disorder-Improvement : CGI-PTSD-I | The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The Clinical Global Impression - PTSD - Improvement scale (CGI-PTSD-I) is a 7 point scale that requires the clinician to assess how much the PTSD has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | Changes from baseline in CGI-PTSD-I at 4-weeks |
| Clinical Global Impressions-Post Traumatic Stress Disorder-Severity : CGI-PTSD-S | The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The Clinical Global Impression -PTSD - Severity scale (CGI-PTSD-S) is a 7-point scale that requires the clinician to rate the severity of the PTSD at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. | Changes from baseline in CGI-PTSD-S at 4-weeks |