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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2032250056

Enrollment

Registered

2025-04-28

Start date

2025-04-28

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

depression patients with advanced or recurrent cancer

Interventions

SMD402 or sham app is used for 12 weeks with standard treatment (Interview for assesssment and treatmend using DCS for psychiatric problems in cancer)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with depression(DSM-5). Patients with advanced(stage III/IV) or recurrent cancer. Patients with smartphone.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in HADS-D at 12 weeks	—

Secondary

Measure	Time frame
HADS-D/HADS-T/HADS-A CGI-I MADRS Proportion of participants with medication of antidepressants Adverse events and software malfunction	—

Countries

Japan, nore

Contacts

Public ContactNui Takahashi

SUSMED, Inc

support@susmed.co.jp+81-3-6366-7780

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026