DepressionPhase 4NCT05026203
Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression
A Phase 4 study testing Ketamine Hydrochloride and Midazolam in people with Depression, run by Mahidol University at 1 site in Thailand.
Trial summary
Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS >= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Ketamine Hydrochloride and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2021to 30 Nov 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 20 years old
- depression was diagnosed by a psychiatrist and having MADRS >= 25
- depression treated with 2 optimal dosage of antidepressants for 4 weeks and one psychotherapy
- stable dosage of current medications for 4 weeks
- fluently Thai
Who cannot join
- secondary depression
- PTSD
- current pregnancy
- history of increased intracranial hemorrhage, increased intracranial pressure, severe head injury, abnormal thyroid function, angina, heart failure, arrhythmia, aneurysm, uncontrolled hypertension, chronic lower tract respiratory disease, myasthenia gravis, glaucoma, dementia, acute porphyria, or cystitic (within 3 months prior to recruitment)
- allergy to ketamine or midazolam
- history of substance use disorder within 1 year prior to recruitment
Show all 11Show fewer
- history of psychosis within 3 months
- history of bipolar disorder
- BMI over 35
- frail medical condition
- currently ECT or TMS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ketamine Treatment in Difficult-to-treat Depression Comparing With Midazolam: a Double-blind Randomized Controlled Trial and Its Cost Effectiveness Analysis
Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS >= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have.
Participants will be randomized into two groups that are intervention (ketamine 0.5 mg/kg IV drip in 40 minutes) and control (midazolam 0.045 mg/kg IV drip in 40 minutes) groups. Participants will administer ketamine/midazolam once daily for three consecutive days. They will be evaluate MADRS changing, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during the treatment, at 1 week and 4 weeks after treatment completion.
- Conditions
- Depression
- Being tested
- Ketamine Hydrochloride, Midazolam
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days
MidazolamDrug
Midazolam
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Not described Receives: Drug: Ketamine Hydrochloride |
| Midazolam | Placebo comparator | Not described Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
decrease more than 50% of scale from baseline is defined as remission
Measured: 1 month
Secondary outcomes (2)
dissociation
The dissociative experiences measure, Oxford (DEMO)
Measured: immediately after administraion
health questionnaire
The 5-level EQ-5D version (EQ-5D-5L)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Jul 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keerati Pattanaseri, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026203
- Sponsor's protocol ID
- 109/2564(IRB1)
- Status last verified
- Mar 2024
- First submitted
- 24 Aug 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pattanaseri K, Lortrakul J, Jaisin K, Srifuengfung M, Sa-Nguanpanich N, Viravan N, Pariwatcharakul P, Makarasara W, Ratta-Apha W. A randomized controlled pilot study of daily intravenous ketamine over three days for treatment-resistant depression. BMC Psychiatry. 2024 Jul 18;24(1):512. doi: 10.1186/s12888-024-05951-5.
PubMed 39026266
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ketamine Treatment in Difficult-to-treat Depression Comparing With Midazolam: a Double-blind Randomized Controlled Trial and Its Cost Effectiveness Analysis
- ClinicalTrials.gov ID
- NCT05026203
- Acronym / sponsor ID
- 109/2564(IRB1)
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Aug 2021 (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.
Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS >= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have.
Participants will be randomized into two groups that are intervention (ketamine 0.5 mg/kg IV drip in 40 minutes) and control (midazolam 0.045 mg/kg IV drip in 40 minutes) groups. Participants will administer ketamine/midazolam once daily for three consecutive days. They will be evaluate MADRS changing, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during the treatment, at 1 week and 4 weeks after treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine Hydrochloride |
| Midazolam | Placebo comparator | Drug: Midazolam |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 20 years old
- depression was diagnosed by a psychiatrist and having MADRS >= 25
- depression treated with 2 optimal dosage of antidepressants for 4 weeks and one psychotherapy
- stable dosage of current medications for 4 weeks
- fluently Thai
Key exclusion criteria (11 listed)
- secondary depression
- PTSD
- current pregnancy
- history of increased intracranial hemorrhage, increased intracranial pressure, severe head injury, abnormal thyroid function, angina, heart failure, arrhythmia, aneurysm, uncontrolled hypertension, chronic lower tract respiratory disease, myasthenia gravis, glaucoma, dementia, acute porphyria, or cystitic (within 3 months prior to recruitment)
- allergy to ketamine or midazolam
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 |
|---|---|---|
| Ketamine HydrochlorideKetamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days | Drug | Ketamine |
| MidazolamMidazolam | Drug | Midazolam |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 1 month
decrease more than 50% of scale from baseline is defined as remission
2 secondary outcomes
dissociation
Time frame: immediately after administraion
health questionnaire
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 39026266Pattanaseri K, Lortrakul J, Jaisin K, Srifuengfung M, Sa-Nguanpanich N, Viravan N, Pariwatcharakul P, Makarasara W, Ratta-Apha W. A randomized controlled pilot study of daily intravenous ketamine over three days for treatment-resistant depression. BMC Psychiatry. 2024 Jul 18;24(1):512. doi: 10.1186/s12888-024-05951-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine Hydrochloride and Midazolam in people with Depression, run by Mahidol University at 1 site in Thailand.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 15 Mar 2024. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05026203, which also lists 1 linked publication.
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 15 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.