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

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ClinicalTrials.gov Identifier: NCT01896388
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Tsuyoshi Sasaki, 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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorders Drug: Ifenprodil Tartrate Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Actual Study Start Date : January 21, 2014
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ifenprodil Tartrate
Oral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper)
Drug: Ifenprodil Tartrate
Placebo Comparator: Placebo
Oral Administration of Placebo (After breakfast, After supper)
Drug: Placebo



Primary Outcome Measures :
  1. The Impact of Event Scale-Revised Japanese Version : IES-R-J [ Time Frame: 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 :
  1. Trauma Symptom Checklist for Children Japanese Version : TSCC-J [ Time Frame: 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.



Other Outcome Measures:
  1. Children's Depression Rating Scale-Revised : CDRS-R [ Time Frame: Changes from baseline in CDRS-R at 4-weeks ]
    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)

  2. Depression Self-Rating Scale for Children Japanese Version: DSRS-C-J [ Time Frame: Changes from baseline in DSRS-C-J at 4-weeks ]
    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.

  3. Clinical Global Impressions-Post Traumatic Stress Disorder-Improvement : CGI-PTSD-I [ Time Frame: Changes from baseline in CGI-PTSD-I at 4-weeks ]

    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.


  4. Clinical Global Impressions-Post Traumatic Stress Disorder-Severity : CGI-PTSD-S [ Time Frame: Changes from baseline in CGI-PTSD-S at 4-weeks ]

    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.




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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

[Inclusion Criteria]

  1. Diagnosis of PTSD based on DSM-IV-TR criteria.
  2. Score of 25 or higher on the IES-R.
  3. currently is an outpatient at Chiba University Hospital Department of Psychiatry or Child Psychiatry .
  4. 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) .
  5. Ages 13 - 18, male or female
  6. be stable on any medications for PTSD treatment they may be taking for the previous 4 weeks prior to enrollment in this study.
  7. Provision of written informed consent by patients and parents or guardian.
  8. must be able to swallow powdered medicine.

[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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896388


Locations
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Japan
Department of Psychiatry, Chiba University School of Medicine Chiba, Chuo-ku, Japan 260-8670
Chiba, Chuo-ku, Japan, 260-8670
Sponsors and Collaborators
Chiba University
Investigators
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Study Chair: Masaomi Iyo, MD,PhD Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
Study Director: 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

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Responsible Party: Tsuyoshi Sasaki, Tsuyoshi Sasaki, Clinical Associate Professor, Chiba University
ClinicalTrials.gov Identifier: NCT01896388     History of Changes
Other Study ID Numbers: G25013
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Tsuyoshi Sasaki, Chiba University:
PTSD/ifenprodil
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Ifenprodil
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents