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

NCT03666390 | Unknown

• 1 other identifier: 107-2314-B-075-063-MY3
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

treatment refractory depression; suicide; ketamine

Outcome Measures

Primary Outcomes (1)

• Reduction rate of suicide symptom

  Reduction rate of suicide symptom postinfusion of ketamine

  4 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days.

Secondary Outcomes (1)

• Reduction rate of depression symptom

  4 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days.

Study Arms (2)

0.5mg/kg Ketamine

EXPERIMENTAL

Anesthesia

Drug: Ketamine

0.045mg/kg Midazolam

ACTIVE COMPARATOR

Benzodiazepine

Drug: Midazolam

Interventions

Ketamine DRUG

We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.

Also known as: Ketalar

0.5mg/kg Ketamine

Midazolam DRUG

We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.

Also known as: Dormicum

0.045mg/kg Midazolam

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depression including unipolar and bipolar depression, according to DSM-IV criteria and MINI (MiniInternational Neuropsychiatric Interview;MINI) diagnostic interview.
• Age ≧ 20y/o \< 65 y/o
• voluntary patients with signed informed consent proved by institutional review board (IRB)

You may not qualify if:

• Major medical conditions (e.g., head injury, epilepsy, severe renal diseases and cancer).
• Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia.
• Pregnancy.
• Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP (phencyclidine)。
• Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan)
• Alcohol abuse / dependence within 6 months.
• Attempt suicide in hospital.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 111, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Suicide

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mu-Hong Chen, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu-Hong Chen, M.D.

CONTACT

886 -2- 28712121; kremer7119@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 0.5mg/kg vs. active placebo (0.045mg/kg Midazolam)

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 11, 2018
• Study Start: September 10, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

TW (1)