Clinical trial NCT01896388: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Posttraumatic Stress Disorders
Keywords: PTSD/ifenprodil
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The Impact of Event Scale-Revised Japanese Version : IES-R-J
timeFrame: Changes from baseline in IES-R-J at 4-weeks
Secondary outcomes:
measure: Trauma Symptom Checklist for Children Japanese Version : TSCC-J
timeFrame: Changes from baseline in TSCC-J at 4-weeks
Other outcomes:
measure: Children's Depression Rating Scale-Revised : CDRS-R
timeFrame: Changes from baseline in CDRS-R at 4-weeks
measure: Depression Self-Rating Scale for Children Japanese Version: DSRS-C-J
timeFrame: Changes from baseline in DSRS-C-J at 4-weeks
measure: Clinical Global Impressions-Post Traumatic Stress Disorder-Improvement : CGI-PTSD-I
timeFrame: Changes from baseline in CGI-PTSD-I at 4-weeks
measure: Clinical Global Impressions-Post Traumatic Stress Disorder-Severity : CGI-PTSD-S
timeFrame: Changes from baseline in CGI-PTSD-S at 4-weeks
Locations:
city: Chiba
country: Japan
facility: Department of Psychiatry, Chiba University School of Medicine Chiba, Chuo-ku, Japan 260-8670
state: Chuo-ku
Study officials:
affiliation: Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
name: Masaomi Iyo, MD,PhD
role: STUDY_CHAIR
affiliation: Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental Health
name: Nobuhisa Kanahara, MD,PhD
role: STUDY_DIRECTOR
affiliation: Department of Psychiatry, Chiba University Graduate School of Medicine
name: Tasuku Hashimoto, MD.PhD
role: STUDY_DIRECTOR
affiliation: Department of Child Psychiatry, Chiba University Hospital
name: Akihiro Shiina, MD,PhD
role: STUDY_DIRECTOR
affiliation: Research Center for Child Mental Development, Chiba University Graduate School of Medicine
name: Tomihisa Niitsu, MD,PhD
role: STUDY_DIRECTOR
References: