Low-dose ketamine infusion among adolescents and young adults with treatment-resistant depression: a randomized, double-blind placebo-control study.

Low-dose ketamine infusion among adolescents and young adults with treatment-resistant depression: a randomized, double-blind placebo-control study. - Low-dose ketamine infusion among adolescents and young adults with treatment-resistant depression.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046148

Enrollment

Registered

2021-12-01

Start date

2022-01-10

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: Two 0.5mg/kg ketamine infusions Arm2: First 0.045mg/kg midazolam infusion and Second 0.5mg/kg ketamine infusion Arm3: Two 0.045mg/kg midazolam infusions

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 >= 13y/o < 30 y/o (3)Body weigh >= 30 kg. (4)Treatment-resistant depression, which is defined as poor or unsatisfactory response to at least two different antidepressants administered at an adequate dosage and for an adequate treatment duration (5)Still prominent depressive symptoms with at least 4-week treatment of medication treatment or psychotherapy (6)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. (9)Abnormal liver function in recent 3 months. (10) Abnormal ECG (i.e.:arrhythmia). (11) Fever or infection in recent 5 days.

Design outcomes

Primary

Measure	Time frame
1. Changes in depressive symptoms measured by Montgomery-Asberg Depression Rating Scale (MADRS) in adolescents with treatment-resistant depression. 2. Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) in adolescents with treatment-resistant depression. 3. Changes in depressive symptoms measured by Children's Depression Rating Scale-Revised (CDRS-R) in adolescents with treatment-resistant depression. [Time Frame: clinical visit or telephone visit evaluation times are Day 1, 2, 3, 4, 5, 6, 7, 14, and 28]	—

Measure

Time frame

1. Changes in depressive symptoms measured by Montgomery-Asberg Depression Rating Scale (MADRS) in adolescents with treatment-resistant depression. 2. Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) in adolescents with treatment-resistant depression. 3. Changes in depressive symptoms measured by Children's Depression Rating Scale-Revised (CDRS-R) in adolescents with treatment-resistant depression. [Time Frame: clinical visit or telephone visit evaluation times are Day 1, 2, 3, 4, 5, 6, 7, 14, and 28]

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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