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

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.

Conditions

• Treatment-resistant Depression
• Major Depressive Disorder

Interventions

DRUG

Midazolam (active placebo)

Arm1: Two 0.045mg/kg midazolam infusions at Day1 and Day3。

DRUG

Ketamine and Midazolam (active placebo)

Arm2: First 0.045mg/kg midazolam infusion and Second 0.5mg/kg ketamine infusion。

DRUG

Ketamine

Arm3: Two 0.5mg/kg ketamine infusions。

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan

  lead OTHER_GOV

Principal Investigators

• Mu-Hong Chen, M.D., Ph.D. · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-15

Primary Completion

2024-11-30

Completion

2024-11-30

Countries

• Taiwan

Study Locations