Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin: a prospective study using randomized, double-blind, placebo controlled clinical trial

Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin: a prospective study using randomized, double-blind, placebo controlled clinical trial - Modulation of the antidepressant response of ketamine by an immunosuppressant and mTORC1 inhibitor, Rapamycin: a prospective study using randomized, double-blind, placebo controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046150

Enrollment

Registered

2021-11-23

Start date

2020-12-02

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

Treatment Resistance Depression

Interventions

oral rapamycin 6 mg + ketamine (0.5mg/kg) infusion oral placebo + ketamine (0.5mg/kg) infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major depressive episode including unipolar and bipolar depression, according to DSM-5

Exclusion criteria

Exclusion criteria: 1.Major medical conditions (e.g., head injury, epilepsy, severe renal diseases and cancer).2.Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia. 3.Pregnancy and Breastfeeding women.4.Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine,PCP (phencyclidine)5.Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan) 6) Alcohol abuse / dependence within 6 months. 7) Allergy to Ketamine and Rapamycin 8)Those unable to express willingness to participate

Design outcomes

Primary

Measure	Time frame
Our aims are to assess the role of rapamycin in ketamine treatment of TRD patients and to test if rapamycin might enhance and prolong the antidepressant effect of ketamine. For that, we will conduct a parallel, randomized, double blind and placebo controlled study.	—

Countries

Asia(except Japan)

Contacts

Public ContactSu Su Tung-Ping

CHENG HSIN GENERAL HOSPITAL Department of Psychiatry

tomsu0402@gmail.com02-28264400

Outcome results

None listed

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