Exploratory specific clinical trial of VR digital therapeutics for rumination symptoms

JRCT ID: jRCTs032220713

Registered date:20/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major Depressive Disorder
• Date of first enrollment: 20/03/2023
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Intervention group: Patients will view the VR digital content daily for 8 weeks, for no more than 15 minutes at a time, with a minimum 12-hours interval between viewings (once/day). Concomitant medical therapy will follow the criteria for the control group. Control group: Patients receive the same dose of standard medication (antidepressant) for 8 weeks.
Antidepressants are not necessarily required for subjects 24 years of age or younger.

Control group: Patients receive the same dose of standard medication (antidepressant) for 8 weeks.

Outcome(s)

• Primary Outcome: Change in total HAM-D score

Secondary Outcome

- Change from baseline in total HAM-D score at 4
and 12 weeks
- Change from baseline in each HAM-D item (e.g., suicide attempts, difficulty falling asleep, etc.) at 4, 8, and 12 weeks
- HAM-D remission rate (=<7 remissions) and time to remission at 4, 8, and 12 weeks
- Change from baseline in RRS antisymptom score at 1-12 weeks
- Change from Baseline in QIDS-SR Depressive Symptom Score at 4, 8, and 12 Weeks
- Change from Baseline in Depressive Symptom Score on the CGI at 4, 8, and 12 Weeks
- Change from baseline in EQ-5D-5L score at 4, 8, and 12 weeks
- Safety endpoints (frequency of adverse events and illness)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Must be at least 18 years of age at the time consent is obtained.
2.Patients with a diagnosis of MDD based on DSM-5.
3.Patients who are refractory to standard pharmacological treatment (SSRIs, SNRIs, NaSSAs, S-RIMs, new antidepressants, up to two additional antianxiety or sleep medication (However, if antianxiety and sleep medication are prescribed together, the total number of pills is limited to three.), and aripiprazole as an augmentation therapy) without improvement or remission.
However, patients 24 years of age or younger (as stated in the "Precautions Related to Indications" section of the package insert for antidepressants, "There are reports of an increased risk of suicidal ideation and suicide attempts. The risks and benefits should be weighed when administering this drug."), including patients who are refractory to standard treatments (psychoeducation, environmental modification, and supportive psychotherapy), in addition to the selection criteria described above in this section.
4.Patients with an RRS antipsychotic score of 42 or higher.
5.Patients with a total HAM-D score of 14 or higher.
6.Patients must be able to wear VR goggles and have no visual or auditory abnormalities.
7.The patient must be able to understand the verbal instructions necessary to carry out the study, and must be able to operate digital devices.
8.Have given written consent to participate in this study.

Exclude criteria

1.Patients with a history of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, epilepsy, delusional disorder, persistent depressive disorder (mood dysphoria), personality disorder, mental retardation, or depression with psychotic features according to DSM-5.
2.Patients with refractory depression (Stage III or
higher by Thase and Rush criteria [1], see Appendix)
3.Patients with clinically diagnosed imminent thoughts of death
4.Patients who have changed medication or started a new treatment within 4 weeks prior to enrollment.
5.Patients who have received systematic psychotherapy such as cognitive-behavioral therapy (excluding supportive care and group cognitive-behavioral therapy) within 4 weeks prior to enrollment.
6.Patients who have used any investigational or unapproved drugs within 8 weeks prior to enrollment (depending on the kinetics of the blood concentration of the administered drug).
7.Patients with a history of electroconvulsive therapy.
8.Patients with a history of magnetic stimulation therapy.
9.Patients who have difficulty wearing VR goggles or viewing VR appropriately due to sensory sensitivity, etc.
10.Patients whose medical conditions make it difficult them to conduct the research.
11.Other patients who are deemed inappropriate as research subjects for this study by the principal investigator.

Related Information

• Primary Sponsor: Matsumura Masayo
• Source(s) of Monetary Support: BiPSEE, Inc.