Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
NCT ID: NCT01896388
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2014-01-21
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ifenprodil Tartrate
Oral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper)
Ifenprodil Tartrate
Placebo
Oral Administration of Placebo (After breakfast, After supper)
Placebo
Interventions
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Ifenprodil Tartrate
Placebo
Eligibility Criteria
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Inclusion 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.
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.
Exclusion Criteria
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.
13 Years
18 Years
ALL
No
Sponsors
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Chiba University
OTHER
Responsible Party
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Tsuyoshi Sasaki
Tsuyoshi Sasaki, Clinical Associate Professor
Principal Investigators
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Masaomi Iyo, MD,PhD
Role: STUDY_CHAIR
Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
Nobuhisa Kanahara, MD,PhD
Role: STUDY_DIRECTOR
Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental Health
Tasuku Hashimoto, MD.PhD
Role: STUDY_DIRECTOR
Department of Psychiatry, Chiba University Graduate School of Medicine
Akihiro Shiina, MD,PhD
Role: STUDY_DIRECTOR
Department of Child Psychiatry, Chiba University Hospital
Tomihisa Niitsu, MD,PhD
Role: STUDY_DIRECTOR
Research Center for Child Mental Development, Chiba University Graduate School of Medicine
Locations
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Department of Psychiatry, Chiba University School of Medicine Chiba, Chuo-ku, Japan 260-8670
Chiba, Chuo-ku, Japan
Countries
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Other Identifiers
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G25013
Identifier Type: -
Identifier Source: org_study_id
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