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

Primary Purpose

Posttraumatic Stress Disorders

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Ifenprodil Tartrate

Placebo

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring PTSD/ifenprodil

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

[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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ifenprodil Tartrate

Placebo

Arm Description

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

Oral Administration of Placebo (After breakfast, After supper)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01896388

First Posted

July 8, 2013

Last Updated

March 17, 2019

Sponsor

Chiba University

1. Study Identification

Unique Protocol Identification Number

NCT01896388

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

January 21, 2014 (Actual)

Primary Completion Date

March 2019 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiba University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorders

Keywords

PTSD/ifenprodil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ifenprodil Tartrate

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral Administration of Placebo (After breakfast, After supper)

Intervention Type

Drug

Intervention Name(s)

Ifenprodil Tartrate

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

The Impact of Event Scale-Revised Japanese Version : IES-R-J

Description

Time Frame

Changes from baseline in IES-R-J at 4-weeks

Secondary Outcome Measure Information:

Title

Trauma Symptom Checklist for Children Japanese Version : TSCC-J

Description

Time Frame

Changes from baseline in TSCC-J at 4-weeks

Other Pre-specified Outcome Measures:

Title

Children's Depression Rating Scale-Revised : CDRS-R

Description

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)

Time Frame

Changes from baseline in CDRS-R at 4-weeks

Title

Depression Self-Rating Scale for Children Japanese Version: DSRS-C-J

Description

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.

Time Frame

Changes from baseline in DSRS-C-J at 4-weeks

Title

Clinical Global Impressions-Post Traumatic Stress Disorder-Improvement : CGI-PTSD-I

Description

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.

Time Frame

Changes from baseline in CGI-PTSD-I at 4-weeks

Title

Clinical Global Impressions-Post Traumatic Stress Disorder-Severity : CGI-PTSD-S

Description

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.

Time Frame

Changes from baseline in CGI-PTSD-S at 4-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

[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.

Overall Study Officials: