Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial

Chiba University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Posttraumatic Stress Disorders

Treatments

Drug: Ifenprodil Tartrate

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01896388

G25013

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

[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.