Low-dose ketamine infusion for adolescents with treatment-resistant depression

Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression: a Randomized, Double-blind Placebo-control Study

This study is testing whether low-dose ketamine can help teenagers aged 13 to 19 who have depression that hasn't improved with other treatments.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 13 Years to 19 Years
• Sex: All
• Sponsor: Taipei Veterans General Hospital, Taiwan (other gov)
• Locations: 1 site (Taipei city)
• Trial ID: NCT05045378 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of low-dose ketamine infusion in adolescents aged 13 to 19 who suffer from treatment-resistant depression (TRD). The study aims to address the high prevalence of TRD in this population, which has been linked to increased risks of suicidality and chronic depressive episodes. Participants will receive either ketamine or an active placebo (midazolam) to evaluate the rapid-acting antidepressant effects of ketamine compared to standard treatments. The trial will include rigorous eligibility criteria to ensure the safety and appropriateness of participants.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 13 to 19 with major depressive disorder who have not responded to at least two different antidepressants.

Not a fit: Patients with major medical conditions, other psychiatric disorders, or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a rapid and effective option for adolescents suffering from severe depression who have not responded to traditional antidepressants.

How similar studies have performed: Previous studies have shown that low-dose ketamine can be effective in treating treatment-resistant depression in adults, suggesting potential for success in adolescents as well.

Eligibility 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 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 this trial is running

Taipei city

• Taipei Veterans General Hospital, Taiwan — Taipei city, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Mu-Hong Chen, M.D., Ph.D. — Taipei Veterans General Hospital, Taiwan
• Study coordinator: Mu-Hong Chen, M.D., Ph.D.

Conditions: Treatment-resistant Depression, Major Depressive Disorder, adolescent, ketamine, N-methyl-D-aspartate receptor antagonist