Major Depressive DisorderNCT03666390
Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide
A study testing Ketamine and Midazolam in people with Major Depressive Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 111
Mu-Hong Chen, M.D.
About this study
Official title: A Double-blind, Randomized-controlled Trial Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Keywords
- treatment refractory depression, suicide, ketamine
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
MidazolamDrug
Also called Dormicum
We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
| Study group | Role | What they receive |
|---|---|---|
| 0.5mg/kg Ketamine | Experimental | Anesthesia Receives: Drug: Ketamine |
| 0.045mg/kg Midazolam | Active comparator | Benzodiazepine Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction rate of suicide symptom
Reduction rate of suicide symptom postinfusion of ketamine
Measured: 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
Reduction rate of depression symptom post-infusion of ketamine
Measured: 4 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start10 Sep 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 0.5mg/kg vs. active placebo (0.045mg/kg Midazolam)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mu-Hong Chen, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666390
- Sponsor's protocol ID
- 107-2314-B-075-063-MY3
- Status last verified
- Sep 2018
- First submitted
- 9 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized-controlled Trial Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide
- ClinicalTrials.gov ID
- NCT03666390
- Acronym / sponsor ID
- 107-2314-B-075-063-MY3
- Conditions
- Major Depressive Disorder
- Keywords
- treatment refractory depression, suicide, ketamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 10 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 0.5mg/kg vs. active placebo (0.045mg/kg Midazolam)
| Arm | Type | Receives |
|---|---|---|
| 0.5mg/kg Ketamine | Experimental | Drug: KetamineAnesthesia |
| 0.045mg/kg Midazolam | Active comparator | Drug: MidazolamBenzodiazepine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: KetalarWe will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations. | Drug | 0.5mg/kg Ketamine |
| MidazolamAlso: DormicumWe will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations. | Drug | 0.045mg/kg Midazolam |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mu-Hong Chen, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Midazolam in people with Major Depressive Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mu-Hong Chen, M.D. (886 -2- 28712121 ext. 2912, kremer7119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.