NIPH Clinical Trials Search

Exproratory study to evaluate the efficacy and safety of SMD402 for depression patients with advanced or recurrent cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	depression patients with advanced or recurrent cancer
Date of first enrollment	28/04/2025
Target sample size	60
Countries of recruitment	nore,Japan
Study type	Interventional
Intervention(s)	SMD402 or sham app is used for 12 weeks with standard treatment (Interview for assesssment and treatmend using DCS for psychiatric problems in cancer)

Outcome(s)

Primary Outcome	Change from baseline in HADS-D at 12 weeks
Secondary Outcome	HADS-D/HADS-T/HADS-A CGI-I MADRS Proportion of participants with medication of antidepressants Adverse events and software malfunction

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with depression(DSM-5). Patients with advanced(stage III/IV) or recurrent cancer. Patients with smartphone.
Exclude criteria	Patients with a HADS-D score of less than 7. Patients under antidepressants or anti-anxiety drugs. Patients who are pregnant, lactating, or possibly pregnant.