Unique ID issued by UMIN | UMIN000011720 |
---|---|
Receipt number | R000013699 |
Scientific Title | Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial |
Date of disclosure of the study information | 2013/09/11 |
Last modified on | 2019/03/15 08:33:50 |
Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Japan |
Post Traumatic Stress Disorder (PTSD)
Psychiatry |
Others
NO
Primary Purpose: Treatment for adolescent PTSD (Age:13-18)
Study Phase: Phase 1/Phase 2
Intervention Model: Parallel Assignment
Number of Arms: 2
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Safety,Efficacy
Primary Outcome Measure:
Title:The Impact of Event Scale-Revised Japanese Version : IES-R-J
Time Frame: Changes from baseline in IES-R-J at 4-weeks
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Central registration
2
Treatment
Medicine |
Ifenprodil Tartrate (28days)
Placebo (28days)
13 | years-old | <= |
18 | years-old | >= |
Male and Female
[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.
40
1st name | Masaomi |
Middle name | |
Last name | Iyo |
Chiba University School of Medicine
Department of Psychiatry
260-8670
1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670
043-222-7171
iyom@faculty.chiba-u.jp
1st name | Tsuyoshi |
Middle name | |
Last name | Sasaki |
Chiba University Hospital
Department of Child Psychiatry
260-8670
1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670
043-222-7171
sasaki@faculty.chiba-u.jp
Department of Psychiatry, Chiba University School of Medicine
Department of Psychiatry, Chiba University School of Medicine
Other
Chiba-University Hospital
1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
043-222-7171
igaku-rinri@office.chiba-u.jp
YES
NCT01896388
Clinical Trials.gov
千葉大学医学部附属病院/Chiba University Hospital
2013 | Year | 09 | Month | 11 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 18 | Day |
2013 | Year | 06 | Month | 18 | Day |
2013 | Year | 09 | Month | 18 | Day |
2018 | Year | 12 | Month | 31 | Day |
2013 | Year | 09 | Month | 11 | Day |
2019 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013699