UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011720
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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.

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

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.

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
Middle name
Last name Iyo
Organization Chiba University School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670
TEL 043-222-7171
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sasaki
Organization Chiba University Hospital
Division name Department of Child Psychiatry
Zip code
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

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.

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
Address
Tel
Email

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
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


Contact us.