UMIN-CTR Clinical Trial
| 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 | 2024/06/02 13:56:13 |
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Basic information
Public title
An open-label trial of memantine for the treatment of posttraumatic stress disorder
Acronym
An open-label trial of memantine for PTSD
Scientific Title
An open-label trial of memantine for the treatment of posttraumatic stress disorder
Scientific Title:Acronym
An open-label trial of memantine for PTSD
Region
| Japan |
Condition
Condition
posttraumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of memantine in the treatment of PTSD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) PTSD diagnosis/severity (PTSD Diagnostic Scale: PDS)
Key secondary outcomes
(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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Memantine intake for 12 weeks
(titrated by 5mg/day weekly to the maintenance dose of 20mg/day)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with posttraumatic stress disorder
(2) Individuals who can understand the nature of this study and provide informed consent
Key exclusion criteria
(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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kim |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
TEL
042-341-2711
kim@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hori |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
TEL
042-341-2711
Homepage URL
hori@ncnp.go.jp
Sponsor or person
Institute
National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurolog y and Psychiatry Clinical Research Review Board
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs031180200
Publication of results
Partially published
Result
URL related to results and publications
https://jrct.niph.go.jp/re/reports/detail/77755
Number of participants that the trial has enrolled
20
Results
In this open clinical trial with a single group pre-post comparison, memantine was shown to be effective against PTSD symptoms and depressive symptoms in civilian female PTSD patients, and was generally well tolerated. The results of this study suggest the usefulness of memantine in the treatment of PTSD. In the future, it is necessary to verify the efficacy and safety of memantine for civilian PTSD patients through RCT.
Results date posted
| 2024 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 20 cases of PTSD patients enrolled in this study, 17 cases for which the necessary follow-up data were obtained were included in the analysis. Mean age of the participants was 33.4 (SD: 6.5) years (range: 25-46 years), and all participants were female. In the majority of patients (88.2%), the traumatic experience that triggered the development of PTSD was interpersonal violence such as abuse in childhood and domestic violence or sexual violence in adulthood. The mean illness duration was 14.1 (SD: 10.4) years (range: 1-33 years). Many patients had comorbid psychiatric disorders such as mood disorders (52.9%) and anxiety disorders (41.1%), and were taking psychotropic drugs including antidepressants (76.4%), benzodiazepines (64.7%), and antipsychotics (29.0%). None of the patients had a history of traumatic brain injury. The mean Posttraumatic Diagnostic Scale (PDS) total score at baseline was 33.6 (SD: 9.8) points, indicating that the patients' average PTSD severity was moderate to severe. The mean Beck Depression Inventory Second Edition (BDI-II) total score at baseline was 30.2(SD: 15.3) points, indicating that depressive symptoms were on average moderate to severe. The average Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total index score at baseline was 84.4 (SD: 19.6), indicating mild cognitive decline.
Participant flow
Informed consent was obtained from 23 patients, of whom 20 participated in the intervention. Necessary follow-up data were obtained in 17 of them. Three patients dropped out because two patients deviated from the protocol due to a change in concomitant psychotropic medication, and one patient was too busy to participate in the study.
Adverse events
No serious adverse events or illnesses were observed. Other adverse events observed included sleep problems, drowsiness, sedation, weight changes, and hypotension, but all were mild.
One patient discontinued memantine because her fasting blood sugar level rose to 120 at 8 weeks after participating in the study. The condition improved during follow-up observation, and a causal relationship with memantine could not be determined.
Outcome measures
Primary outcome: PTSD diagnosis/severity (PTSD Diagnostic Scale: PDS)
Secondary outcomes:
(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)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025044
