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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 : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Tracking Information
First Submitted Date  ICMJE September 7, 2021
First Posted Date  ICMJE September 16, 2021
Last Update Posted Date October 25, 2021
Estimated Study Start Date  ICMJE October 2021
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2021)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2021)
To assess the rapid antidepressant effect of low-dose ketamine infusion 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 ]
We evaluate the changes of total depression scores of depression scales, including Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Rating Scale for Depression (HAMD), and Children's Depression Rating Scale-Revised (CDRS-R). Higher MADRS score indicates more severe depression. The overall score ranges from 0 to 60. Higher HAMD score indicates more severe depression. The overall score ranges from 0 to 52. Higher CDRS-R score indicates more severe depression. The overall score ranges from 17 to 113.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression
Official Title  ICMJE Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression: a Randomized, Double-blind Placebo-control Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Treatment-resistant Depression
  • Major Depressive Disorder
Intervention  ICMJE
  • 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。
Study Arms  ICMJE
  • Active Comparator: 1. Two 0.045mg/kg midazolam infusions
    Two 0.045mg/kg midazolam infusions as active placebo
    Intervention: Drug: Midazolam (active placebo)
  • Experimental: 2. First 0.045mg/kg midazolam infusion and Second 0.5mg/kg ketamine infusion
    Single ketamine infusion + Single midazolam placebo infusion
    Intervention: Drug: Ketamine and Midazolam (active placebo)
  • Experimental: 3. Two 0.5mg/kg ketamine infusions
    Repeated (Two) ketamine infusions: Two 0.5mg/kg ketamine infusions
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2021)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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。
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mu-Hong Chen, M.D., Ph.D. +886 2 28757027 kremer7119@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05045378
Other Study ID Numbers  ICMJE 2020-02-015A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taipei Veterans General Hospital, Taiwan
Study Sponsor  ICMJE Taipei Veterans General Hospital, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taipei Veterans General Hospital, Taiwan
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP