UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000011720|
|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|
|Public title||Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial|
|Acronym||Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial|
|Condition||Post Traumatic Stress Disorder (PTSD)|
|Classification by specialty||
|Classification by malignancy||Others|
|Narrative objectives1||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)
Endpoint Classification: Safety/Efficacy Study
|Basic objectives -Others|
|Primary outcomes||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
|Key secondary outcomes|
|In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.|
|Blinding||Double blind -all involved are blinded|
|No. of arms||2|
|Purpose of intervention||Treatment|
|Type of intervention||
|Interventions/Control_1||Ifenprodil Tartrate (28days)|
|In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.|
|Gender||Male and Female|
|Key inclusion 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.
|Key exclusion criteria||[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.
|Target sample size||40|
|Research contact person|
|Name of lead principal investigator||
|Organization||Chiba University School of Medicine|
|Division name||Department of Psychiatry|
|Address||1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670|
|Name of contact person||
|Organization||Chiba University Hospital|
|Division name||Department of Child Psychiatry|
|Address||1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670|
|Institute||Department of Psychiatry, Chiba University School of Medicine|
|Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.
|Organization||Department of Psychiatry, Chiba University School of Medicine|
|Category of Funding Organization||Other|
|Nationality of Funding Organization|
|Other related organizations|
|Name of secondary funder(s)|
|IRB Contact (For public release)|
|Org. issuing International ID_1||Clinical Trials.gov|
|Org. issuing International ID_2|
|IND to MHLW|
|Institutions||千葉大学医学部附属病院/Chiba University Hospital|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date||
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
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