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

NCT01896388 | Completed Phase 1 DMC

• 1 other identifier: G25013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorders

Keywords

PTSD/ifenprodil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Trauma Symptom Checklist for Children Japanese Version : TSCC-J

  Changes from baseline in TSCC-J at 4-weeks

Other Outcomes (4)

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

  Changes from baseline in CDRS-R at 4-weeks

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

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

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

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

Study Arms (2)

Ifenprodil Tartrate

ACTIVE COMPARATOR

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

Drug: Ifenprodil Tartrate

Placebo

PLACEBO COMPARATOR

Oral Administration of Placebo (After breakfast, After supper)

Drug: Placebo

Interventions

Ifenprodil Tartrate DRUG

Ifenprodil Tartrate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Chiba University: lead

Study Sites (1)

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

Chiba, Chuo-ku, 260-8670, Japan

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

ifenprodil

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tsuyoshi Sasaki, Clinical Associate Professor

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: January 21, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

JP (1)