UMIN-CTR Clinical Trial

Public title

Feasibility study of VR digital therapies in MDD patients

Acronym

VRT 2201

Scientific Title

An 8-week, multicenter, randomized trial to evaluate the efficacy and safety of VR digital therapies in patients with major depressive disorder who are inadequately responding to antidepressants

Scientific Title:Acronym

VRT 2201

Region

Asia(except Japan)

Condition

Depression (DSM-5) / Major depressive disorder (MDD)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy
The change in the total HAM-D score from baseline and at week 8

Key secondary outcomes

The change in each item of HAMD. E.g., suicide attempt, difficulty in getting to sleep, from baseline and at week 8
The change in total HAMD from baseline and at week 12
The change in the rumination symptom score, RRS, from baseline at week 8
The change in the patient's CGI depressive symptom score from baseline at week 8
The change in the WHOQoLBREF score from baseline at week 8
Records of the names of rumination episodes and the frequency of rumination
Adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Active arm: VR digital therapies + standard drug therapy
13 weeks (1 week of screening + 8 weeks of administration period + 4 weeks of follow-up).Patients wear VR goggles and view VR digital treatment drug contents with a frequency of once a week. For the standard drug therapy, the type and dosage and administration will not be changed from the time of screening to the end of the treatment period.

Interventions/Control_2

Control arm: Standard drug therapy

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Age: 18 years of age or older.
2. Patients who were diagnosed as having depression (DSM-5)/major depressive disorder (MDD) triggered by, or independent of, infection with SARS-CoV-2
3. Patients who received a definite diagnosis of MDD (single episode or recurrent episodes) in a DSM-5 structured interview (SCID-5) at the start of screening and had a depressive episode duration of 8 weeks to 12 months at the start of screening.
4. Patients with a rumination symptom score on the Ruminative Response Scale (RRS) of 42 or higher at the start of screening and baseline5. Patients who have not responded to one antidepressant (SSRI, SNRI, NaSSA, or TCA/non-TCA)
5. One antianxiety medication, one sleep medication, and aripiprazole as augmentation therapy, all in sufficient doses are allowed, for at least four weeks prior to the start of screening
6. Patients with a total HAM-D score of 13 to 17 at the start of screening and baseline.
7. Patients who are able to wear VR goggles.
8. Patients who are able to understand verbal instructions necessary for research accomplishment and to enter data using a smartphone or tablet.

Key exclusion criteria

1. Patients who have met a diagnostic criterion for schizophrenia, schizoaffective psychosis, schizophreniform disorder, bipolar disorder, delusional disorder, persistent depressive disorder (dysthymia), personality disorder, mental retardation, or depression with psychotic features in accordance with DSM-5 in the evaluation at the start of screening.
2. Patients whose primary therapeutic objective was another mental disorder (other than those mentioned in the Exclusion criteria #1) within six months prior to the start of screening or at baseline (based on a clinical judgment by the investigator at each site).
3. Patients receiving lithium, valproic acid, carbamazepine, or lamotrigine within six months prior to the start of screening or at baseline.
4. Patients who started a new therapy for MDD treatment within four weeks prior to the start of screening.
5. Patients with refractory depression (Stage III or higher according to the Thase and Rush scale)
6. Patients clinically judged as having suicidal attempts during the screening period or at baseline.
7. Patients who have received electroconvulsive therapy (ECT).
8. Patients who have received magnetic stimulation therapy (rTMS therapy).
9. Patients who received structured psychotherapy (excluding supportive psychotherapy), such as cognitive behavior therapy, from four weeks prior to the start of screening.
10. Patients who are diagnosed with epilepsy.
11. Patients who are considered difficult to accomplish research due to their condition.
12. Patients who are difficult to wear VR goggles for reasons, such as hypersensibility, or who are difficult to properly view VR.
13. Other patients who are considered ineligible by the investigator (sub-investigators).

Target sample size

100

Name of lead principal investigator

1st name	Masayo
Middle name
Last name	Matsumura

Organization

Kochi University

Division name

Medical School

Zip code

783-8505

Address

Kohasu, Oko-cho, Nankoku, Kochi

TEL

088-880-2218

Email

mmatsumura@kochi-u.ac.jp

Name of contact person

1st name	Naoki
Middle name
Last name	Tomotsugu

Organization

National Center for Global Health and Medicine

Division name

Department of International Trials, Center for Clinical Sciences

Zip code

162-8655

Address

1-21-1 Toyama Shinjuku-ku, Tokyo

TEL

03-6228-0445

Homepage URL

Email

ntomotsugu@hosp.ncgm.go.jp

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Mahidol University Siriraj Hospital

Name of secondary funder(s)

Mahidol University Ramathibodi Hospital

Organization

Mahidol University

Address

999 Phutthamonthon 4 Rd., Salaya, Phutthamonthon, Nakhon Pathom 73170, Thailand

Tel

(+66)-2849-6220

Email

mucerif.mahidol@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

10

Month

16

Day

Date of IRB

Anticipated trial start date

2023

Year

11

Month

27

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

26

Day

Last modified on

2023

Year

11

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059343