UMIN-CTR Clinical Trial
| 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 |
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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
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
iyom@faculty.chiba-u.jp
Public contact
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
sasaki@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013699
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| Registered date | File name |
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