Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin: A double-blind, randomized, placebo controlled trial combined with the neuropsychological and functional connectivity MRI study.

Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin: A double-blind, randomized, placebo controlled trial combined with the neuropsychological and functional connectivity MRI study. - Modulation of the antidepressant and antisuicidal efficacy of low-dose ketamine infusion via the mTORC1 modulator, Rapamycin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049877

Enrollment

Registered

2023-01-01

Start date

2023-01-01

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-resistant depression

Interventions

Arm1: Ketamine (0.5mg/kg) infusion and oral rapamycin (6mg) at three time points Arm2: Ketamine (0.5mg/kg) infusion and oral placebo at three time points

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Major depressive episode including unipolar and bipolar depression, according to DSM-5 criteria and MINI-adolescent version (Mini-International Neuropsychiatric Interview; MINI) diagnostic interview. (2) Age >= 20y/o < 70 y/o (3) Voluntary patients and their parents or guardians with signed informed consent proved by institutional review board (IRB)

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. (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) Attempt suicide in hospital. (8) Allergy to ketamine or rapamycin.

Design outcomes

Primary

Measure	Time frame
1. Changes in depressive symptoms measured by Montgomery-Asberg Depression Rating Scale (MADRS) in adults with treatment-resistant depression. 2. Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) in adults with treatment-resistant depression.	—

Countries

Asia(except Japan)

Contacts

Public ContactMu-Hong Chen

Taipei Veterans General Hospital, Taiwan Department of Psychiatry

kremer7119@gmail.com+886228757027

Outcome results

None listed

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