Depression, BipolarECTNCT04399070
The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)
A study testing S-ketamine, ketamine and saline in people with Depression, Bipolar and Depression, Unipolar, run by Yan Qiu at 1 site in China.
Trial summary
This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Bipolar, Depression, Unipolar, Major Depressive Disorder
- What is being tested?
- S-ketamine, ketamine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Jan 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status I-II
- diagnose depressive disorders with DSM-IV
- Without cognitive impairment
- Without ECT in past 6 months
Who cannot join
- had other comorbid psychiatric diagnoses, including schizophrenia, mania
- organic heart diseases, severe hypertension and arrhythmia
- severe hepatic and renal diseases
- severe cerebrovascular disorder or malformation, intracranial mass lesions and seizure
- glaucoma or high intraocular pressure and intra-ocular pathology
- severe haematological disease, fracture and obesity, pregnancy
Show all 12Show fewer
- severe respiratory tract disease or difficult ventilation or incubation
- had pre-existing neurological disease or cognitive impairment
- allergy to anesthetics
- drugs abuse or alcohol addiction
- family history of malignant hyperthemia
- refuse to participate in this trial, had taken part in other clinical trial and with less education and couldn't understand the content of questionnaire
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Sichuan University, Department of Anesthesiology
Chengdu, Sichuan, 610041
Guizhi Du, Doctor, +86-189-8060-2213, du_guizhi@yahoo.com
About this study
Official title: Effect of S-ketamine on Depressed Patients Undergoing Electroconvulsive Therapy-a Randomized, Double-blind, Controlled Clinical Study
This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy.
Read the detailed description
Nowadays, depression has become one of the serious mental diseases that affect human's life. With the acceleration of life pace and social pressure, the incidence of depression is increasing year-on-year. According to the statistics of the WHO, by 2017, there were more than 300 million people suffering from depression, accounting for 4.4% of the global population. Depression is highly related to suicide, which is an important reason for suicidal intention and attempt. It has been demonstrated that the incidence of suicide associated with major depression was as high as 15%. The main characteristic of depression is significant and lasting depression, which is caused by the decrease of monoamine transmitters (including dopamine, 5-HT, et al.) related to mood. In the past, antidepressants mainly relied on increasing or reducing the metabolism of transmitters, but these drugs usually took weeks or even months to take effect, and although the symptoms of depression were relieved within weeks after the start of treatment, they were still not ideal in the long term. Therefore, the drug treatment of depression is not optimistic.
Electroconvulsive therapy (ECT), as the first biological therapy introduced into psychiatry, has been improving with the progress of technology and equipment. More studies show that ECT is a safe and effective treatment, and the treatment of severe depression is the first choice in some cases. However, cognitive dysfunction, relapse tendency and related safety after ECT need further study.
Short acting sedatives and muscle relaxants before ECT can minimize the fear and muscle pain caused by ECT induced seizures. Previous sedatives used include propofol, mesaclopidol, thiopental and ketamine. Ketamine can be used for ECT anesthesia in patients with depression because of its good epileptic characteristics and prevention of cognitive dysfunction after ECT. More evidences reveal ketamine has strong antidepressant effect and reduces suicide of patients with treatment-resistant depression or mania. The low dose of ketamine can take effect within one hour, produce rapid antidepressant effect, and can play a role in more than 70% of patients with refractory depression. In addition, even a single intravenous injection of ketamine can effectively reduce the symptoms of depression within 24-72 hours, and may have synergistic antidepressant effect when combined with ECT. Although ketamine is considered to have a significant antidepressant effect in patients with depression, its application in mental disorders remains to be further explored because it may aggravate mental symptoms. However, some studies also found that ketamine did not significantly improve the effect of ECT on depression compared with other anesthetics.
Esketamine is the isomer of ketamine, which mainly acts on NMDA receptor of glutamate and its affinity to the receptor is 3-4 times that of ketamine, therefore it has stronger effect. Evidence suggests that esketamine can regulate NMDA receptor, increase the release of various neurotransmitters, improve the depression of patients, and repair the damaged neurons to improve the neuronal connections in the brain. As an anesthetic, the potency of esketamine is two times higher than ketamine, three times higher than R-ketamine, and its drug metabolism time is shorter, and the related side effects are also significantly reduced. Conseuqently, it has been widely used as an anesthetic in some countries. The efficacy and safety of esketamine nasal spray as a rapid and effective antidepressant in the treatment of patients with refractory depression have been confirmed. However the effect of intravenous esketamine as an anesthetic in ECT anesthesia on patients who are depressed remains unknown. The aim of this study is to evaluate the short-term effect and safety of esketamine as a adjunctive anesthetic in routine ECT anesthesia for patients with depression.
- Conditions
- Depression, Bipolar, Depression, Unipolar, Major Depressive Disorder, Manic-Depressive - Now Depressed
- Being tested
- S-ketamine, ketamine, saline
- Keywords
- Electroconvulsive therapy, Depression, S-ketamine
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamineDrug
The depression patients received propofol and S-ketamine before ECT
ketamineDrug
The depression patients received propofol and ketamine before ECT
salineDrug
The depression patients received propofol and saline before ECT
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Placebo comparator | patients were treated with propofol 1 mg/kg and saline bolus infusion before ECT Receives: Drug: saline |
| Ketamine group | Active comparator | patients were treated with propofol 1 mg/kg and ketamine 0.5 mg/kg bolus infusion before ECT Receives: Drug: ketamine |
| S-ketamine group | Experimental | patients were treated with propofol 1 mg/kg and S-ketamine 0.25 mg/kg bolus infusion before ECT Receives: Drug: S-ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale-17 scores
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
Measured: the 1 day after the last ECT
Montgomery-Asberg Depression Rating Scale scores
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
Measured: the 1 day after the last ECT
Secondary outcomes (18)
Hamilton Depression Scale-17 scores
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions before ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
Measured: baseline (before first ECT)
Hamilton Depression Scale-17 scores
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
Measured: one week after the first ECT
Hamilton Depression Scale-17 scores
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
Measured: one month after the last ECT
Montgomery-Asberg Depression Rating Scale scores
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores before ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
Measured: baseline (before first ECT)
Montgomery-Asberg Depression Rating Scale scores
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
Measured: one week after the first ECT
Montgomery-Asberg Depression Rating Scale scores
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
Measured: one month after the last ECT
Mini-mental State Examination scores
the patients' cognitive function were evaluated with Mini-mental State Examination scores before ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
Measured: baseline (before first ECT)
Mini-mental State Examination scores
the patients' cognitive function were evaluated with Mini-mental State Examination scores after ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
Measured: one week after the first ECT
Mini-mental State Examination scores
the patients' cognitive function were evaluated with Mini-mental State Examination scores after ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
Measured: the 1 day after the last ECT
Mini-mental State Examination scores
the patients' cognitive function were evaluated with Mini-mental State Examination scores after ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
Measured: one month after the last ECT
suicide
adverse events
Measured: times of symptomatic episodes from first ECT up to one month after last ECT
Mean heart rate before ECT
patients' vital sign
Measured: 5 minutes before each ECT
Mean heart rate after ECT
patients' vital sign
Measured: 5 minutes after patients emergency from each ECT
Mean Arterial Pressure before ECT
patients' vital sign
Measured: 5 minutes before each ECT
Mean Arterial Pressure after ECT
patients' vital sign
Measured: 5 minutes after patients emergency from each ECT
Mean time for return of spontaneous respiration after ECT
time for return of spontaneous respiration after ECT
Measured: from end of ECT to return of spontaneous respiration after each ECT
Mean emergency time after ECT
patients' recovery time after ECT
Measured: from end of ECT to eye opening or following commands after each ECT
Mean seizure duration during ECT
patients' seizure duration during ECT
Measured: from end of electrical stimulus to clonic movements in the right lower limb during each ECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Aug 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Depression, BipolarStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Qiu, West China Hospital
- Investigators
- Guizhi Du, Doctor, Principal investigator, West China Hospital of Sichuan University, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399070
- Sponsor's protocol ID
- West China Hospital Anes
- Acronym
- ECT
- Status last verified
- Jul 2020
- First submitted
- 8 May 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. Depression and other common mental disorders: Global health estimates. Geneva: World Health Organization. 2017.
Ribeiro JD, Huang X, Fox KR, Franklin JC. Depression and hopelessness as risk factors for suicide ideation, attempts and death: meta-analysis of longitudinal studies. Br J Psychiatry. 2018 May;212(5):279-286. doi: 10.1192/bjp.2018.27. Epub 2018 Mar 28.
PubMed 29587888Rong C, Park C, Rosenblat JD, Subramaniapillai M, Zuckerman H, Fus D, Lee YL, Pan Z, Brietzke E, Mansur RB, Cha DS, Lui LMW, McIntyre RS. Predictors of Response to Ketamine in Treatment Resistant Major Depressive Disorder and Bipolar Disorder. Int J Environ Res Public Health. 2018 Apr 17;15(4):771. doi: 10.3390/ijerph15040771.
PubMed 29673146Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Lisanby SH; CORE/PRIDE Work Group. Right Unilateral Ultrabrief Pulse ECT in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1101-1109. doi: 10.1176/appi.ajp.2016.15081101. Epub 2016 Jul 15.
PubMed 27418379Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Dooley M, Lisanby SH; CORE/PRIDE Work Group. A Novel Strategy for Continuation ECT in Geriatric Depression: Phase 2 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1110-1118. doi: 10.1176/appi.ajp.2016.16010118. Epub 2016 Jul 15.
PubMed 27418381Fond G, Bennabi D, Haffen E, Brunel L, Micoulaud-Franchi JA, Loundou A, Lancon C, Llorca PM, Auquier P, Boyer L. A Bayesian framework systematic review and meta-analysis of anesthetic agents effectiveness/tolerability profile in electroconvulsive therapy for major depression. Sci Rep. 2016 Jan 25;6:19847. doi: 10.1038/srep19847.
PubMed 26806849Hashimoto K. Rapid-acting antidepressant ketamine, its metabolites and other candidates: A historical overview and future perspective. Psychiatry Clin Neurosci. 2019 Oct;73(10):613-627. doi: 10.1111/pcn.12902. Epub 2019 Jul 11.
PubMed 31215725Li DJ, Wang FC, Chu CS, Chen TY, Tang CH, Yang WC, Chow PC, Wu CK, Tseng PT, Lin PY. Significant treatment effect of add-on ketamine anesthesia in electroconvulsive therapy in depressive patients: A meta-analysis. Eur Neuropsychopharmacol. 2017 Jan;27(1):29-41. doi: 10.1016/j.euroneuro.2016.11.008. Epub 2016 Nov 28.
PubMed 27908572Erdil F, Ozgul U, Colak C, Cumurcu B, Durmus M. Effect of the Addition of Ketamine to Sevoflurane Anesthesia on Seizure Duration in Electroconvulsive Therapy. J ECT. 2015 Sep;31(3):182-5. doi: 10.1097/YCT.0000000000000225.
PubMed 25719444Kishimoto T, Chawla JM, Hagi K, Zarate CA, Kane JM, Bauer M, Correll CU. Single-dose infusion ketamine and non-ketamine N-methyl-d-aspartate receptor antagonists for unipolar and bipolar depression: a meta-analysis of efficacy, safety and time trajectories. Psychol Med. 2016 May;46(7):1459-72. doi: 10.1017/S0033291716000064. Epub 2016 Feb 12.
PubMed 26867988Wilkinson ST, Ballard ED, Bloch MH, Mathew SJ, Murrough JW, Feder A, Sos P, Wang G, Zarate CA Jr, Sanacora G. The Effect of a Single Dose of Intravenous Ketamine on Suicidal Ideation: A Systematic Review and Individual Participant Data Meta-Analysis. Am J Psychiatry. 2018 Feb 1;175(2):150-158. doi: 10.1176/appi.ajp.2017.17040472. Epub 2017 Oct 3.
PubMed 28969441Zhang K, Hashimoto K. An update on ketamine and its two enantiomers as rapid-acting antidepressants. Expert Rev Neurother. 2019 Jan;19(1):83-92. doi: 10.1080/14737175.2019.1554434. Epub 2018 Dec 4.
PubMed 30513009Sackeim HA. Modern Electroconvulsive Therapy: Vastly Improved yet Greatly Underused. JAMA Psychiatry. 2017 Aug 1;74(8):779-780. doi: 10.1001/jamapsychiatry.2017.1670. No abstract available.
PubMed 28658461Carspecken CW, Borisovskaya A, Lan ST, Heller K, Buchholz J, Ruskin D, Rozet I. Ketamine Anesthesia Does Not Improve Depression Scores in Electroconvulsive Therapy: A Randomized Clinical Trial. J Neurosurg Anesthesiol. 2018 Oct;30(4):305-313. doi: 10.1097/ANA.0000000000000511.
PubMed 29847468Zheng W, Li XH, Zhu XM, Cai DB, Yang XH, Ungvari GS, Ng CH, Ning YP, Hu YD, He SH, Wang G, Xiang YT. Adjunctive ketamine and electroconvulsive therapy for major depressive disorder: A meta-analysis of randomized controlled trials. J Affect Disord. 2019 May 1;250:123-131. doi: 10.1016/j.jad.2019.02.044. Epub 2019 Feb 18.
PubMed 30852364
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of S-ketamine on Depressed Patients Undergoing Electroconvulsive Therapy-a Randomized, Double-blind, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04399070
- Acronym / sponsor ID
- ECT / West China Hospital Anes
- Conditions
- Depression, Bipolar, Depression, Unipolar, Major Depressive Disorder, Manic-Depressive - Now Depressed
- Keywords
- Electroconvulsive therapy, Depression, S-ketamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yan QiuUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 22 May 2020 (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.
This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy.
Detailed description
Nowadays, depression has become one of the serious mental diseases that affect human's life. With the acceleration of life pace and social pressure, the incidence of depression is increasing year-on-year. According to the statistics of the WHO, by 2017, there were more than 300 million people suffering from depression, accounting for 4.4% of the global population. Depression is highly related to suicide, which is an important reason for suicidal intention and attempt. It has been demonstrated that the incidence of suicide associated with major depression was as high as 15%. The main characteristic of depression is significant and lasting depression, which is caused by the decrease of monoamine transmitters (including dopamine, 5-HT, et al.) related to mood. In the past, antidepressants mainly relied on increasing or reducing the metabolism of transmitters, but these drugs usually took weeks or even months to take effect, and although the symptoms of depression were relieved within weeks after the start of treatment, they were still not ideal in the long term. Therefore, the drug treatment of depression is not optimistic.
Electroconvulsive therapy (ECT), as the first biological therapy introduced into psychiatry, has been improving with the progress of technology and equipment. More studies show that ECT is a safe and effective treatment, and the treatment of severe depression is the first choice in some cases. However, cognitive dysfunction, relapse tendency and related safety after ECT need further study.
Short acting sedatives and muscle relaxants before ECT can minimize the fear and muscle pain caused by ECT induced seizures. Previous sedatives used include propofol, mesaclopidol, thiopental and ketamine. Ketamine can be used for ECT anesthesia in patients with depression because of its good epileptic characteristics and prevention of cognitive dysfunction after ECT. More evidences reveal ketamine has strong antidepressant effect and reduces suicide of patients with treatment-resistant depression or mania. The low dose of ketamine can take effect within one hour, produce rapid antidepressant effect, and can play a role in more than 70% of patients with refractory depression. In addition, even a single intravenous injection of ketamine can effectively reduce the symptoms of depression within 24-72 hours, and may have synergistic antidepressant effect when combined with ECT. Although ketamine is considered to have a significant antidepressant effect in patients with depression, its application in mental disorders remains to be further explored because it may aggravate mental symptoms. However, some studies also found that ketamine did not significantly improve the effect of ECT on depression compared with other anesthetics.
Esketamine is the isomer of ketamine, which mainly acts on NMDA receptor of glutamate and its affinity to the receptor is 3-4 times that of ketamine, therefore it has stronger effect. Evidence suggests that esketamine can regulate NMDA receptor, increase the release of various neurotransmitters, improve the depression of patients, and repair the damaged neurons to improve the neuronal connections in the brain. As an anesthetic, the potency of esketamine is two times higher than ketamine, three times higher than R-ketamine, and its drug metabolism time is shorter, and the related side effects are also significantly reduced. Conseuqently, it has been widely used as an anesthetic in some countries. The efficacy and safety of esketamine nasal spray as a rapid and effective antidepressant in the treatment of patients with refractory depression have been confirmed. However the effect of intravenous esketamine as an anesthetic in ECT anesthesia on patients who are depressed remains unknown. The aim of this study is to evaluate the short-term effect and safety of esketamine as a adjunctive anesthetic in routine ECT anesthesia for patients with depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Placebo comparator | Drug: salinepatients were treated with propofol 1 mg/kg and saline bolus infusion before ECT |
| Ketamine group | Active comparator | Drug: ketaminepatients were treated with propofol 1 mg/kg and ketamine 0.5 mg/kg bolus infusion before ECT |
| S-ketamine group | Experimental | Drug: S-ketaminepatients were treated with propofol 1 mg/kg and S-ketamine 0.25 mg/kg bolus infusion before ECT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) Physical Status I-II
- diagnose depressive disorders with DSM-IV
- Without cognitive impairment
- Without ECT in past 6 months
Key exclusion criteria (12 listed)
- had other comorbid psychiatric diagnoses, including schizophrenia, mania
- organic heart diseases, severe hypertension and arrhythmia
- severe hepatic and renal diseases
- severe cerebrovascular disorder or malformation, intracranial mass lesions and seizure
- glaucoma or high intraocular pressure and intra-ocular pathology
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 |
|---|---|---|
| S-ketamineThe depression patients received propofol and S-ketamine before ECT | Drug | S-ketamine group |
| ketamineThe depression patients received propofol and ketamine before ECT | Drug | Ketamine group |
| salineThe depression patients received propofol and saline before ECT | Drug | Propofol group |
Primary outcome
Hamilton Depression Scale-17 scores
Time frame: the 1 day after the last ECT
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
Montgomery-Asberg Depression Rating Scale scores
Time frame: the 1 day after the last ECT
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
18 secondary outcomes
Hamilton Depression Scale-17 scores
Time frame: baseline (before first ECT)
Hamilton Depression Scale-17 scores
Time frame: one week after the first ECT
Hamilton Depression Scale-17 scores
Time frame: one month after the last ECT
Montgomery-Asberg Depression Rating Scale scores
Time frame: baseline (before first ECT)
Montgomery-Asberg Depression Rating Scale scores
Time frame: one week after the first ECT
Montgomery-Asberg Depression Rating Scale scores
Time frame: one month after the last ECT
Mini-mental State Examination scores
Time frame: baseline (before first ECT)
Mini-mental State Examination scores
Time frame: one week after the first ECT
Mini-mental State Examination scores
Time frame: the 1 day after the last ECT
Mini-mental State Examination scores
Time frame: one month after the last ECT
suicide
Time frame: times of symptomatic episodes from first ECT up to one month after last ECT
Mean heart rate before ECT
Time frame: 5 minutes before each ECT
Mean heart rate after ECT
Time frame: 5 minutes after patients emergency from each ECT
Mean Arterial Pressure before ECT
Time frame: 5 minutes before each ECT
Mean Arterial Pressure after ECT
Time frame: 5 minutes after patients emergency from each ECT
Mean time for return of spontaneous respiration after ECT
Time frame: from end of ECT to return of spontaneous respiration after each ECT
Mean emergency time after ECT
Time frame: from end of ECT to eye opening or following commands after each ECT
Mean seizure duration during ECT
Time frame: from end of electrical stimulus to clonic movements in the right lower limb during each ECT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- BackgroundWorld Health Organization. Depression and other common mental disorders: Global health estimates. Geneva: World Health Organization. 2017.
- Background: PubMed 29587888Ribeiro JD, Huang X, Fox KR, Franklin JC. Depression and hopelessness as risk factors for suicide ideation, attempts and death: meta-analysis of longitudinal studies. Br J Psychiatry. 2018 May;212(5):279-286. doi: 10.1192/bjp.2018.27. Epub 2018 Mar 28.
- Background: PubMed 29673146Rong C, Park C, Rosenblat JD, Subramaniapillai M, Zuckerman H, Fus D, Lee YL, Pan Z, Brietzke E, Mansur RB, Cha DS, Lui LMW, McIntyre RS. Predictors of Response to Ketamine in Treatment Resistant Major Depressive Disorder and Bipolar Disorder. Int J Environ Res Public Health. 2018 Apr 17;15(4):771. doi: 10.3390/ijerph15040771.
- Background: PubMed 27418379Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Lisanby SH; CORE/PRIDE Work Group. Right Unilateral Ultrabrief Pulse ECT in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1101-1109. doi: 10.1176/appi.ajp.2016.15081101. Epub 2016 Jul 15.
- Background: PubMed 27418381Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Dooley M, Lisanby SH; CORE/PRIDE Work Group. A Novel Strategy for Continuation ECT in Geriatric Depression: Phase 2 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1110-1118. doi: 10.1176/appi.ajp.2016.16010118. Epub 2016 Jul 15.
- Background: PubMed 26806849Fond G, Bennabi D, Haffen E, Brunel L, Micoulaud-Franchi JA, Loundou A, Lancon C, Llorca PM, Auquier P, Boyer L. A Bayesian framework systematic review and meta-analysis of anesthetic agents effectiveness/tolerability profile in electroconvulsive therapy for major depression. Sci Rep. 2016 Jan 25;6:19847. doi: 10.1038/srep19847.
- Background: PubMed 31215725Hashimoto K. Rapid-acting antidepressant ketamine, its metabolites and other candidates: A historical overview and future perspective. Psychiatry Clin Neurosci. 2019 Oct;73(10):613-627. doi: 10.1111/pcn.12902. Epub 2019 Jul 11.
- Background: PubMed 27908572Li DJ, Wang FC, Chu CS, Chen TY, Tang CH, Yang WC, Chow PC, Wu CK, Tseng PT, Lin PY. Significant treatment effect of add-on ketamine anesthesia in electroconvulsive therapy in depressive patients: A meta-analysis. Eur Neuropsychopharmacol. 2017 Jan;27(1):29-41. doi: 10.1016/j.euroneuro.2016.11.008. Epub 2016 Nov 28.
- Background: PubMed 25719444Erdil F, Ozgul U, Colak C, Cumurcu B, Durmus M. Effect of the Addition of Ketamine to Sevoflurane Anesthesia on Seizure Duration in Electroconvulsive Therapy. J ECT. 2015 Sep;31(3):182-5. doi: 10.1097/YCT.0000000000000225.
- Background: PubMed 26867988Kishimoto T, Chawla JM, Hagi K, Zarate CA, Kane JM, Bauer M, Correll CU. Single-dose infusion ketamine and non-ketamine N-methyl-d-aspartate receptor antagonists for unipolar and bipolar depression: a meta-analysis of efficacy, safety and time trajectories. Psychol Med. 2016 May;46(7):1459-72. doi: 10.1017/S0033291716000064. Epub 2016 Feb 12.
- Background: PubMed 28969441Wilkinson ST, Ballard ED, Bloch MH, Mathew SJ, Murrough JW, Feder A, Sos P, Wang G, Zarate CA Jr, Sanacora G. The Effect of a Single Dose of Intravenous Ketamine on Suicidal Ideation: A Systematic Review and Individual Participant Data Meta-Analysis. Am J Psychiatry. 2018 Feb 1;175(2):150-158. doi: 10.1176/appi.ajp.2017.17040472. Epub 2017 Oct 3.
- Background: PubMed 30513009Zhang K, Hashimoto K. An update on ketamine and its two enantiomers as rapid-acting antidepressants. Expert Rev Neurother. 2019 Jan;19(1):83-92. doi: 10.1080/14737175.2019.1554434. Epub 2018 Dec 4.
- Individual participant dataSharing planned: No
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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.
Guizhi Du, Doctor principal investigator
West China Hospital of Sichuan University, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-ketamine, ketamine and saline in people with Depression, Bipolar and Depression, Unipolar, run by Yan Qiu at 1 site in China.
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 4 inclusion and 12 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 22 Jul 2020. 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 China. 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.
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 Yan Qiu, Doctor (+8618980606269, qiuyan_mz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale-17 scores (time frame: the 1 day after the last ECT). The study lists 2 primary outcomes in all. 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 NCT04399070, which also lists 18 linked publications.
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 22 Jul 2020.