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CompletedPhase 4

Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression

NCT05045378 · Taipei Veterans General Hospital, Taiwan

Closed to entry
Status
Not accepting participants
Phase 4
Phase
12
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

In the past decades, the prevalence of adolescent depression and suicide increased significantly in Taiwan and worldwide. To date, the suicide mortality is the second mortality cause in the adolescent and young adult population in Taiwan. Previous studies reported that up to 40% of adolescents with major depressive disorder did not respond to at least two traditional antidepressants with the optimal dose and adequate duration. Those patients would be considered the cases with treatment-resistant depression (TRD), which is related to the poor prognosis, chronic depressive course, higher suicidal risk, severer cognitive dysfunction, and greater family burdens. However, much less studies investigated the treatment strategy for adolescent TRD compared with that for adult TRD. In this decade, low-dose ketamine infusion has been proved as a rapid-acting antidepressant for adult patients with TRD. In recent 5 years, the investigators study team finished two randomized, double-blind, and placebo-control trials to support the rapid antidepressant and anti-suicidal effect in Taiwanese adult patients with TRD. The investigators published several SCI studies about the investigators clinical findings and the underlying brain mechanisms. In the following 4 years, the investigators will conduct a new randomized, double-blind, and placebo-control trial in the adolescent TRD. It will be the first clinical trial for ketamine effect in adolescent TRD worldwide. The investigators will enroll 54 adolescents aged between 13 and 29 with TRD in four years. The investigators hypothesize that low-dose ketamine will be effective and well tolerable for adolescents with TRD.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in depressive symptoms measured by Montgomery-Åsberg Depression Rating Scale (MADRS) in adolescents with treatment-resistant depression.

    Measured over clinical visit or telephone visit evaluation times are Day 1, 2, 3, 4, 5, 6, 7, 14, and 28

  • Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) in adolescents with treatment-resistant depression.

    Measured over clinical visit or telephone visit evaluation times are Day 1, 2, 3, 4, 5, 6, 7, 14, and 28

  • Changes in depressive symptoms measured by Children's Depression Rating Scale-Revised (CDRS-R) in adolescents with treatment-resistant depression.

    Measured over clinical visit or telephone visit evaluation times are Day 1, 2, 3, 4, 5, 6, 7, 14, and 28

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

13 Years to 29 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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 13 to 19 years old. 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: 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。

Where

1 study site

FacilityCityRegionCountry
Taipei Veterans General Hospital, TaiwanTaipeiTaiwan

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05045378 on ClinicalTrials.gov →

Last updated in the registry 2025-09-05. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits