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Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide

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ClinicalTrials.gov Identifier: NCT03666390
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Tracking Information
First Submitted Date  ICMJE September 9, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date September 19, 2018
Estimated Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
Reduction rate of suicide symptom [ Time Frame: 4 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days. ]
Reduction rate of suicide symptom postinfusion of ketamine
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
Decreasing rate of suicide symptom [ Time Frame: 240mins, day 1 to 7, day 14. ]
Decreasing rate of suicide symptom postinfusion of ketamine
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
Reduction rate of depression symptom [ Time Frame: 4 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days. ]
Reduction rate of depression symptom post-infusion of ketamine
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
Decreasing rate of depression symptom [ Time Frame: 240mins, day 1 to 7, day 14. ]
Decreasing rate of depression symptom post-infusion of ketamine
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide
Official Title  ICMJE A Double-blind, Randomized-controlled Trial Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide
Brief Summary Depression and suicide are two leading mental health and public health issues in Taiwan. However, until now, the optimal treatment for refractory depression and suicide is still lacking. Previous USA studies suggested a low dose NMDA antagonist Ketamine infusion can significantly reduce depression and suicide. In our study, we firstly investigate the anti-suicide and anti-depressive effects of ketamine in Taiwan. If we can find the similar antidepressant and anti-suicide of ketamine in Taiwanese, this result will have a great influence in the current suicide and depression prevention programs.
Detailed Description

Depression and suicide are major issues of public health worldwide. However, there is time-lag for current available antidepressants to have therapeutic effective. In fact, if partial responses were also included, up to 50% of depressed patients showed little or no response to traditional antidepressant medication treatments. In addition, suicide is also a prevalent mental health problem worldwide and still has no optimal and effective treatment now. In Taiwan, the annual suicide rate increased gradually despite of the suicide prevention program. Ketamine, a kind of N-methyl-D-aspartate receptor (NMDAR) antagonist, is a FDA-approved anesthetic agent. One single sub-anesthesia dose of ketamine infusion can rapidly improve refractory depression without side effects of dependence, and its antidepressant effects have been proved by some double-blind and randomized controlled trials in other countries. However, it has not been investigated and validated in Han Chinese population. The mechanism of rapid antidepressant effects is still unknown. Besides, much less studies assessed the anti-suicide efficacy of a low dose of ketamine infusion.

Under the support of NSC 101-2314-B-010-060 and NSC 101-2314-B-010-061, we finished the study of a single dose ketamine infusion in the treatment of refractory major depression (TRD) using a double blind randomized placebo-controlled fashion. Three groups with each 24 patients of TRD received 0.5mg/kg, 0.2mg/kg and placebo (PBO) respectively. The primary outcome assessed by MADRS and HAMD depression ratings disclosed about 40~45% response. Also, a single low dose of ketamine could reduce approximately 50% suicide-related symptoms based on the subanalysis of ketamine treatment efficacy for specific suicide item.

In current study, we plan to recruit 48 subjects of TRD within two years in double-blind, randomized - controlled fashion with each year 24 subjects, who will receive 0.5mg/kg vs. active placebo (0.045mg/kg Midazolam) equally. Mood symptom changes by MARDRS and HAMD ratings, suicide scales, and impulsivity and loneliness scales will be conducted at different time points from baseline to the 14th day. We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations. If it is successful, it would be able to generalize to benefit for the huge population of Chinese in the world.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
0.5mg/kg vs. active placebo (0.045mg/kg Midazolam)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
    Other Name: Ketalar
  • Drug: Midazolam
    We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
    Other Name: Dormicum
Study Arms  ICMJE
  • Experimental: 0.5mg/kg Ketamine
    Anesthesia
    Intervention: Drug: Ketamine
  • Active Comparator: 0.045mg/kg Midazolam
    Benzodiazepine
    Intervention: Drug: Midazolam
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Major depression including unipolar and bipolar depression, according to DSM-IV criteria and MINI (MiniInternational Neuropsychiatric Interview;MINI) diagnostic interview.
  2. Age ≧ 20y/o < 65 y/o
  3. voluntary patients 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mu-Hong Chen, M.D. 886 -2- 28712121 ext 2912 kremer7119@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03666390
Other Study ID Numbers  ICMJE 107-2314-B-075-063-MY3
Has Data Monitoring Committee No
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
Plan to Share IPD: Undecided
Responsible Party Taipei Veterans General Hospital, Taiwan
Study Sponsor  ICMJE Taipei Veterans General Hospital, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mu-Hong Chen, M.D. Taipei Veterans General Hospital, Taiwan
PRS Account Taipei Veterans General Hospital, Taiwan
Verification Date September 2018

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