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 2023/06/01 16:46:44

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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

Email

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


Email

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

Email

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


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

20

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

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

2023 Year 06 Month 01 Day



Link to view the page

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