Unique ID issued by UMIN | UMIN000022467 |
---|---|
Receipt number | R000025044 |
Scientific Title | An open-label trial of memantine for the treatment of posttraumatic stress disorder |
Date of disclosure of the study information | 2016/05/27 |
Last modified on | 2023/06/01 16:46:44 |
An open-label trial of memantine for the treatment of posttraumatic stress disorder
An open-label trial of memantine for PTSD
An open-label trial of memantine for the treatment of posttraumatic stress disorder
An open-label trial of memantine for PTSD
Japan |
posttraumatic stress disorder
Psychiatry |
Others
NO
To examine the efficacy and safety of memantine in the treatment of PTSD
Safety,Efficacy
(1) PTSD diagnosis/severity (PTSD Diagnostic Scale: PDS)
(1) PTSD severity (Impact of Event Scale-Revised: IES-R)
(2) Cognitive function (Repeatable Battery for the Assessment of Neuropsychological Status: RBANS)
(3) Depressive symptoms (Beck Depression Inventory-II)
(4) Anxiety symptoms (State-Trait Anxiety Inventory)
(5) Cognitive changes after traumatic events (Posttraumatic Cognitions Inventory)
(6) Overall symptom severity/improvement (Clinical Global Impression)
(7) Adverse events (UKU Side-Effect Rating Scale)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Memantine intake for 12 weeks
(titrated by 5mg/day weekly to the maintenance dose of 20mg/day)
20 | years-old | <= |
60 | years-old | > |
Male and Female
(1) Patients diagnosed with posttraumatic stress disorder
(2) Individuals who can understand the nature of this study and provide informed consent
(1) Patients with duration of illness less than 6 months
(2) Individuals who received specific psychotherapy (e.g., prolonged exposure therapy, cognitive processing therapy, and eye movement desensitization and reprocessing therapy) within 3 months prior to the recruitment into the study
(3) Patients with comorbid schizophrenia, severe manic phase of bipolar disorder, or intellectual disability
(4) Individuals with serious suicidal ideation
(5) Individuals with severe physical illnesses that can interfere with study participation
(6) Pregnant women
(7) Individuals with the following physical conditions that are described in manufacturer's package insert as "careful administration":
-History of epilepsy or convulsion
-Renal dysfunction
-Factors increasing urine pH
-Severe liver dysfunction
(8) Patients considered unqualified for the study by their attending physicians
20
1st name | Yoshiharu |
Middle name | |
Last name | Kim |
National Institute of Mental Health, National Center of Neurology and Psychiatry
Department of Behavioral Medicine
187-8553
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
042-341-2711
kim@ncnp.go.jp
1st name | Hiroaki |
Middle name | |
Last name | Hori |
National Institute of Mental Health, National Center of Neurology and Psychiatry
Department of Behavioral Medicine
187-8553
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
042-341-2711
hori@ncnp.go.jp
National Institute of Mental Health, National Center of Neurology and Psychiatry
National Center of Neurology and Psychiatry
Other
National Center of Neurolog y and Psychiatry Clinical Research Review Board
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
042-341-2711
rinri-jimu@ncnp.go.jp
NO
2016 | Year | 05 | Month | 27 | Day |
Partially published
20
No longer recruiting
2016 | Year | 04 | Month | 18 | Day |
2016 | Year | 04 | Month | 18 | Day |
2016 | Year | 05 | Month | 27 | Day |
2023 | Year | 03 | Month | 30 | Day |
2016 | Year | 05 | Month | 26 | Day |
2023 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025044
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |