Status:
COMPLETED
Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Lead Sponsor:
Chiba University
Conditions:
Posttraumatic Stress Disorders
Eligibility:
All Genders
13-18 years
Phase:
PHASE1
PHASE2
Brief 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 ant...
Eligibility Criteria
Inclusion
- \[Inclusion Criteria\]
- 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.
Exclusion
Key Trial Info
Start Date :
January 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01896388
Start Date
January 21 2014
End Date
March 1 2019
Last Update
March 19 2019
Active Locations (1)
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1
Department of Psychiatry, Chiba University School of Medicine Chiba, Chuo-ku, Japan 260-8670
Chiba, Chuo-ku, Japan, 260-8670