Skip to content

Pivotal clinical trial to assess the efficacy and safety of Affective disorder therapy software(BlueK are-T) in patients with depressive disorder

Pivotal clinical trial to assess the efficacy and safety of Affective disorder therapy software(BlueK are-T) in patients with depressive disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010758
Enrollment
110
Registered
2025-07-15
Start date
2023-10-25
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Disital Therapeutics) : This study consists of an 8-week intervention program, with each group receiving the following interventions: ? Experimental Group (BlueKare-T Intervention Group) Parti

Sponsors

HippoT&C
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Individuals aged 19 years or older 2) Individuals who meet the diagnostic criteria for Major Depressive Disorder according to the DSM-5, or who have been diagnosed with a Depressive Episode (F32) according to the ICD-10 at the time of screening 3)Individuals with a BDI score of 14 or higher 4)Individuals who have no difficulty reading and writing in Korean 5)Individuals who have no difficulty using mobile applications on general-purpose devices (e.g., smartphones or tablet PCs) 6)Individuals who have received a sufficient explanation about the clinical trial, fully understand the information, voluntarily agree to participate, and provide written consent to comply with the study instructions

Exclusion criteria

Exclusion criteria: 1)Individuals with serious psychiatric disorders other than depressive disorder, such as bipolar disorder, schizophrenia, or substance use disorders, or with clinically significant neurological disorders and brain injuries (e.g., stroke, cerebral hemorrhage, multiple sclerosis, epilepsy), or with clinically significant physical illnesses (e.g., liver failure, malignant diseases, metabolic disorders, infectious diseases) 2)Individuals who have attempted suicide within one month prior to screening, or who are deemed to be at high risk of suicide by a psychiatrist 3)Individuals who are undergoing psychotherapy for depression (e.g., cognitive behavioral therapy, interpersonal therapy, psychoanalytic psychotherapy, or psychoanalysis) within three months prior to screening 4)Individuals who have had changes in dosage of allowed concomitant medications for depression—such as antidepressants, mood stabilizers, or antipsychotics—within one month prior to screening ? This exclusion does not apply if the type and dosage of medications remain unchanged during the month prior to screening (including continued prescriptions). Dosage adjustments are allowed within one month prior to screening for the following medications: propranolol, benztropine, trihexyphenidyl HCl, benzodiazepines (e.g., diazepam, clonazepam, bromazepam, lorazepam, alprazolam, triazolam), benzodiazepine-like drugs (e.g., etizolam), zolpidem, and zolpiclone. 5)Individuals deemed by the investigator to be otherwise unsuitable for participation in the clinical trial for any reason

Design outcomes

Primary

MeasureTime frame
Beck Depression Inventory

Secondary

MeasureTime frame
Patient Health Questionnaire-9 ;Montgomery-Åsberg Depression Rating Scale;Beck Anxiety Inventory;Short Form 36-Item Health Survey;Korean Version of the Perceived Stress Scale;Rosenberg Self-Esteem Scale

Countries

Korea, Republic of

Contacts

Public ContactHongjin Jeon

Sungkyunkwan University

jhj001001@gmail.com+82-2-2001-2214

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026