An Exploratory Study of FHM-001 in Patients with Depression

JRCT ID: jRCT2022210028

Registered date:19/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: depression (DSM-5)* (single episode or recurrent)
• Date of first enrollment: 03/09/2021
• Target sample size: 143
• Study type: Interventional
• Intervention(s): Use FHM-001 or control app for 8 weeks in addition to standard of care

Outcome(s)

• Primary Outcome: HAM-D (17 items) total score (change from baseline at Week 8)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

(1)Japanese patients aged 18 to less than 65 years who provided appropriate written informed consent
(2)Ongoing episodes with primary diagnosis of non-psychotic depression (DSM -5)
(3)A total score of > 10 on the PHQ -9 scale and a total score of > 17 on the HAM-D (17 items) scale by the central assessment.
(4)Subject must have a Clinical Global Impression of Change (CGI-I) score of > 3 (mild improvement) and no response or partial response, in the opinion of the investigator, to any single standard of care antidepressant [Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin and Noradrenaline Reuptake Inhibitors (SNRI), Noradrenergic and Specific Serotonergic Antidepressants (NaSSA)] after at least 4 weeks of stable treatment.
(5)Patients who have been taking one of the antidepressants used as standard of care drugs (SSRIs, SNRIs, NaSSAs) at a fixed dosage and administration for 4 weeks or longer and who are judged by the investigator/subinvestigator to have no problem with tolerability and to be able to continue the treatment without changing the dosage and administration

Exclude criteria

(1)Patients with previous or current schizophrenia or other psychotic disorders, or bipolar disorder or other related disorders, based on the diagnostic criteria in the DSM-5
(2)Patients with any of the following disorders based on the diagnostic criteria in the DSM-5: Delirium, dementia, substance-related disorder, borderline personality disorder, eating disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, intellectual disability, and autistic spectrum disorder
(3)Patients with a significant risk of suicide who have had suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) type 4 or 5 within the past 3 months or committed suicidal behavior within 1 year prior to the start of the screening period
(4)Patients under hospitalization, or patients scheduled to be hospitalized for the treatment of a physical disorder or depression during the study period
(5)Patients who have received systematic individual psychotherapy (cognitive behavioral therapy [CBT], interpersonal therapy, dynamic psychotherapy, problem-solving therapy, psychoanalytic therapy, etc.) for the episode concerned
(6)Patients who have received electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) for the episode concerned
(7)Patients who cannot use antidepressants (SSRI, SNRI, or NaSSA) specified as the standard treatments
(8)Patients with a history of diagnosis or treatment of malignancy within 5 years before the start of the screening period, or patients with current malignancy
(9)Female patients who are pregnant, breastfeeding, or may be pregnant
(10)Male patients and female patients of childbearing potential who do not agree to practice contraception during the study period
(11)Patients who have participated in a clinical study of a CBT application and used the CBT application

Related Information

• Primary Sponsor: Furukawa Toshiaki