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

This double-blind, randomised, placebo-controlled trial (n=54) will assess the safety and efficacy of low-dose ketamine infusion as an add-on treatment for adolescents with treatment-resistant depression (TRD).

The study, sponsored by Taipei Veterans General Hospital, Taiwan, aims to enrol adolescents aged 13 to 19 with TRD, defined as poor response to at least two antidepressants. The trial will investigate whether 0.5 mg/kg ketamine infusion is a safe and effective treatment for reducing depressive symptoms and suicidal ideation. Previous studies have shown promising results with ketamine in adult TRD, but this will be the first clinical trial to explore its effects in adolescents.

Participants will be monitored for changes in depression severity, suicidal thoughts, and overall safety of the treatment. The study commenced in March 2022 and is expected to complete in December 2026.

Trial Details

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 19 with TRD in four years. The investigators hypothesize that low-dose ketamine will be effective and well tolerable for adolescents with TRD.

NCT Number NCT05045378

Data attribution

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