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

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ClinicalTrials.gov Identifier: NCT05045378
Recruitment Status : Not yet recruiting
First Posted : September 16, 2021
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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

Condition or disease Intervention/treatment Phase
Treatment-resistant Depression Major Depressive Disorder Drug: Midazolam (active placebo) Drug: Ketamine and Midazolam (active placebo) Drug: Ketamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression: a Randomized, Double-blind Placebo-control Study
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1. Two 0.045mg/kg midazolam infusions
Two 0.045mg/kg midazolam infusions as active placebo
Drug: Midazolam (active placebo)
Arm1: Two 0.045mg/kg midazolam infusions at Day1 and Day3。

Experimental: 2. First 0.045mg/kg midazolam infusion and Second 0.5mg/kg ketamine infusion
Single ketamine infusion + Single midazolam placebo infusion
Drug: Ketamine and Midazolam (active placebo)
Arm2: First 0.045mg/kg midazolam infusion and Second 0.5mg/kg ketamine infusion。

Experimental: 3. Two 0.5mg/kg ketamine infusions
Repeated (Two) ketamine infusions: Two 0.5mg/kg ketamine infusions
Drug: Ketamine
Arm3: Two 0.5mg/kg ketamine infusions。




Primary Outcome Measures :
  1. Changes in depressive symptoms measured by Montgomery-Åsberg Depression Rating Scale (MADRS) 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 ]
    Higher MADRS score indicates more severe depression. The overall score ranges from 0 to 60.

  2. Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) 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 ]
    Higher HAMD score indicates more severe depression. The overall score ranges from 0 to 52.

  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 ]
    Higher CDRS-R score indicates more severe depression. The overall score ranges from 17 to 113.



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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05045378


Contacts
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Contact: Mu-Hong Chen, M.D., Ph.D. +886 2 28757027 kremer7119@gmail.com

Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Mu-Hong Chen, M.D., Ph.D. Taipei Veterans General Hospital, Taiwan
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT05045378    
Other Study ID Numbers: 2020-02-015A
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
adolescent
ketamine
N-methyl-D-aspartate receptor (NMDAR) antagonist
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents