UMIN-CTR Clinical Trial

Basic information
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
Scientific Title	Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Scientific Title:Acronym	Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Region	Japan

Condition
Condition	Post Traumatic Stress Disorder (PTSD)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
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) Allocation: Randomized Endpoint Classification: Safety/Efficacy Study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ifenprodil Tartrate (28days)
Interventions/Control_2	Placebo (28days)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	13 years-old <=
Age-upper limit	18 years-old >=
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
Last name of lead principal investigator	1st name Masaomi Middle name Last name Iyo
Organization	Chiba University School of Medicine
Division name	Department of Psychiatry
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670
TEL	043-222-7171
Email	iyom@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Tsuyoshi Middle name Last name Sasaki
Organization	Chiba University Hospital
Division name	Department of Child Psychiatry
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670
TEL	043-222-7171
Homepage URL
Email	sasaki@faculty.chiba-u.jp

Sponsor
Institute	Department of Psychiatry, Chiba University School of Medicine
Institute
Department

Funding Source
Organization	Department of Psychiatry, Chiba University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba-University Hospital
Address	1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
Tel	043-222-7171
Email	igaku-rinri@office.chiba-u.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01896388
Org. issuing International ID_1	Clinical Trials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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	2013 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 18 Day
Date of IRB	2013 Year 06 Month 18 Day
Anticipated trial start date	2013 Year 09 Month 18 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 11 Day
Last modified on	2019 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013699