Posttraumatic Stress DisordersPhase 1/2NCT01896388
Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
A Phase 1/2 study testing Ifenprodil Tartrate in people with Posttraumatic Stress Disorders, run by Chiba University at 1 site in Japan.
Trial summary
Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Ifenprodil Tartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jan 2014to Mar 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
[Inclusion Criteria]
- Diagnosis of PTSD based on DSM-IV-TR criteria.
- Score of 25 or higher on the IES-R.
- currently is an outpatient at Chiba University Hospital Department of Psychiatry or Child Psychiatry .
- 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) .
- Ages 13 - 18, male or female
- be stable on any medications for PTSD treatment they may be taking for the previous 4 weeks prior to enrollment in this study.
- Provision of written informed consent by patients and parents or guardian.
- must be able to swallow powdered medicine.
[Exclusion Criteria]
- History of allergic reaction or hypersensitivity to Ifenprodil Tartrate.
- Patients who have not stopped bleeding after intracranial hemorrhage.
- Patients who have not been informed of having the disease at the time of informed consent.
- 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) .
- Somatic disorder which requires severe body management or severe meal management.
- 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.
- 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.
- pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study.
- participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention).
- planning change of treatment because of unstable neurological manifestations or somatic symptoms.
- History of suicidal ideation within the past year.
- Other clinically significant reasons for exclusion by investigators.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Psychiatry, Chiba University School of Medicine Chiba, Chuo-ku, Japan 260-8670
Chiba, Chuo-ku, 260-8670
About this study
Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD. The purpose of this study is to confirm whether ifenprodil tartrate is effective in the treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these patients, this study contributes to the development of novel therapeutic drugs for PTSD.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Ifenprodil Tartrate, Placebo
- Keywords
- PTSD/ifenprodil
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifenprodil TartrateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ifenprodil Tartrate | Active comparator | Oral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper) Receives: Drug: Ifenprodil Tartrate |
| Placebo | Placebo comparator | Oral Administration of Placebo (After breakfast, After supper) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Impact of Event Scale-Revised Japanese Version : IES-R-J
Evidence includes retest reliability and internal consistency of the IES-R-J. Posttraumatic stress disorder (PTSD) and partial PTSD cases indicated significantly higher scores than non-PTSD cases. The IES-R-J can be a useful self-rating diagnostic instrument particularly for survivors with PTSD symptoms as a clinical concern (PTSD + partial PTSD) by using a 24/25 cutoff in total score. The IES-R-J can be used as a validated instrument in future international comparative research.
Measured: Changes from baseline in IES-R-J at 4-weeks
Secondary outcomes (1)
Trauma Symptom Checklist for Children Japanese Version : TSCC-J
The TSCC allows you to measure posttraumatic stress and related psychological symptomatology in children ages 8-16 years who have experienced traumatic events, such as physical or sexual abuse, major loss, or natural disasters, or who have been a witness to violence.
The 54-item TSCC includes two validity scales (Underresponse and Hyperresponse), six clinical scales (Anxiety, Depression, Anger, Posttraumatic Stress, Dissociation, and Sexual Concerns), and eight critical items. Profile Forms allow for conversion of raw scores to age- and sex-appropriate T scores and enable you to graph the results.
The TSCC-A, an alternate 44-item version of the measure, makes no reference to sexual issues.
Measured: Changes from baseline in TSCC-J at 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study start21 Jan 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsuyoshi Sasaki, Chiba University
- Investigators
- Masaomi Iyo, MD,PhD, Study chair, Chairman, Department of Psychiatry, Chiba University Graduate School of MedicineNobuhisa Kanahara, MD,PhD, Study director, Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental HealthTasuku Hashimoto, MD.PhD, Study director, Department of Psychiatry, Chiba University Graduate School of MedicineAkihiro Shiina, MD,PhD, Study director, Department of Child Psychiatry, Chiba University HospitalTomihisa Niitsu, MD,PhD, Study director, Research Center for Child Mental Development, Chiba University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896388
- Sponsor's protocol ID
- G25013
- Status last verified
- Mar 2019
- First submitted
- 8 Jul 2013
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01896388
- Acronym / sponsor ID
- G25013
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- PTSD/ifenprodil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- 21 Jan 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD. The purpose of this study is to confirm whether ifenprodil tartrate is effective in the treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these patients, this study contributes to the development of novel therapeutic drugs for PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ifenprodil Tartrate | Active comparator | Drug: Ifenprodil TartrateOral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper) |
| Placebo | Placebo comparator | Drug: PlaceboOral Administration of Placebo (After breakfast, After supper) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifenprodil Tartrate | Drug | Ifenprodil Tartrate |
| Placebo | Drug | Placebo |
Primary outcome
The Impact of Event Scale-Revised Japanese Version : IES-R-J
Time frame: Changes from baseline in IES-R-J at 4-weeks
Evidence includes retest reliability and internal consistency of the IES-R-J. Posttraumatic stress disorder (PTSD) and partial PTSD cases indicated significantly higher scores than non-PTSD cases. The IES-R-J can be a useful self-rating diagnostic instrument particularly for survivors with PTSD symptoms as a clinical concern (PTSD + partial PTSD) by using a 24/25 cutoff in total score. The IES-R-J can be used as a validated instrument in future international comparative research.
1 secondary outcome
Trauma Symptom Checklist for Children Japanese Version : TSCC-J
Time frame: Changes from baseline in TSCC-J at 4-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaomi Iyo, MD,PhD study chair
Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
Nobuhisa Kanahara, MD,PhD study director
Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental Health
Tasuku Hashimoto, MD.PhD study director
Department of Psychiatry, Chiba University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ifenprodil Tartrate in people with Posttraumatic Stress Disorders, run by Chiba University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Impact of Event Scale-Revised Japanese Version : IES-R-J (time frame: Changes from baseline in IES-R-J at 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.