Depressive SymptomsPhase 4NCT02305394

Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy

A Phase 4 study testing ketamine and propofol and propofol and normal saline in people with Depressive Symptoms and Impaired Cognition, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depressive Symptoms, Impaired Cognition, Electroconvulsive Therapy
What is being tested?: ketamine and propofol and propofol and normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 1 siteChina
Study dates: Jan 2015to Feb 2017
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnosed with moderate or severe depression according to Diagnostic and Statistical Manual of Mental Disorders
aged from 18 to 65 years old

Who cannot join

cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;
classification of American Society of Anesthesiologists physical status score IV or V;
complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;
presence of a foreign body such as pacemaker, intracranial electrode, and clips;
history of seizures;
history of drug abuse;

Show all 11Show fewer

concomitant presence of a mental disorder;
pregnancy;
history of serious adverse effects related to anesthetics;
refusal to consent for the study, or refusal to undergo one single ECT during the first week of therapy.
hyperthyreosis

Trial locations and contacts

1 site in 1 country.

Qibin Chen, Master contact

023-89011061

403497559@qq.com

China1 site

China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Su Min, MD, +86-23-89011068, ms89011068@163.com

Other trials in China

About this study

Official title: Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy ---a Randomized Control Double-Blind Clinical Trial

Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the current antidepressant agents，but the most important side effect is cognitive dysfunction. The purpose of this study is to determine whether subanesthetic dose of ketamine combined with propofol is superior to propofol anesthesia alone in improving cognitive function in depressive patients undergoing ECT.

Read the detailed description

Depression is one of the most debilitating and widespread illnesses affecting up to 20% of individuals in their lifetime. However, the current antidepressant agents take weeks to work, and fail to help at least 40% of depressed patients. Electroconvulsive therapy (ECT) is a remarkably effective treatment for depression, but its use is limited by cognitive dysfunction.

As a result, it is becoming a clinical problem which need to be settled urgently. Previous clinical study showed that subanesthetic dose of ketamine could play a role in antidepressant effects with safety and minimal positive psychotic symptoms.The investigators also found that subanesthetic dose of ketamine combined with other anesthetics could improve cognitive function in depressive rats receiving electroconvulsive shock (a model for analogy with ECT). Few clinical researches concerned the effects of subanesthetic dose of ketamine combined with propofol anesthesia on cognitive function in patients after ECT, therefore the investigators conduct this randomized controlled double-blind trial. In this study, cognitive function will be rated by Mini-Mental State examination score.

Conditions: Depressive Symptoms, Impaired Cognition, Electroconvulsive Therapy
Being tested: ketamine and propofol, propofol and normal saline
Keywords: ketamine, Electroconvulsive Therapy, Cognitive Function
Medical subject headings: Depression, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ketamine and propofolDrug
propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.
propofol and normal salineDrug
propofol 1.5 mg/kg and normal saline [weight(kg)×0.3÷10]ml will be administered to participants separately by intravenous infusion.

Study groups in NCT02305394
Study group	Role	What they receive
PK group (ketamine and propofol)	Experimental	propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity. Receives: Drug: ketamine and propofol
P group (propofol group)	Active comparator	propofol 1.5 mg/kg and normal saline [weight(kg)×0.3÷10]ml will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity. Receives: Drug: propofol and normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Mini-Mental State examination score
Mini-Mental State examination score will be measured at 24 hours after the sixth ECT.
Measured: at 24 hours after the sixth ECT

Secondary outcomes (5)

Mini-Mental State examination score
Mini-Mental State examination score will be measured at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.
Measured: at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.
Effects on Antidepression (Hamilton Depression Rating Scale(HDRS)
Effect on antidepression will be measured by 24-item Hamilton Depression Rating Scale(HDRS)
Measured: at 24 hours before the first ECT and 24 hours after each ECT
Seizure Duration and Seizure Energy Index
Seizure duration and Seizure energy index will be recorded by the ECT apparatus.
Measured: at 30 seconds after each ECT
Brief Psychiatric Rating Scale（BPRS）
Brief Psychiatric Rating Scale is related to psychotomimetic side-effect.
Measured: 60 minutes prior to the first ECT and at 40, 80, 110, and 230 minutes after each ECT
Adverse Effects include nausea, vomit, headache, tachycardia and increased blood pressure.
Adverse effects include nausea, vomit, headache, tachycardia and increased blood pressure.
Measured: at 40 minutes after each ECT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Feb 2017

First posted2 Dec 2014 (estimated)
Study startJan 2015
Primary completionDec 2016 (estimated)
Study completionFeb 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Depressive SymptomsStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital of Chongqing Medical 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: 132 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02305394
Sponsor's protocol ID: CYYYMZ-006
Status last verified: Nov 2014
First submitted: 19 Nov 2014
Last updated: 2 Dec 2014
Results posted: No
Data monitoring committee: No

Publications

Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.
PubMed 19397926
Garcia LS, Comim CM, Valvassori SS, Reus GZ, Barbosa LM, Andreazza AC, Stertz L, Fries GR, Gavioli EC, Kapczinski F, Quevedo J. Acute administration of ketamine induces antidepressant-like effects in the forced swimming test and increases BDNF levels in the rat hippocampus. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Jan 1;32(1):140-4. doi: 10.1016/j.pnpbp.2007.07.027. Epub 2007 Aug 8.
PubMed 17884272
Berton O, Nestler EJ. New approaches to antidepressant drug discovery: beyond monoamines. Nat Rev Neurosci. 2006 Feb;7(2):137-51. doi: 10.1038/nrn1846.
PubMed 16429123
Pigot M, Andrade C, Loo C. Pharmacological attenuation of electroconvulsive therapy--induced cognitive deficits: theoretical background and clinical findings. J ECT. 2008 Mar;24(1):57-67. doi: 10.1097/YCT.0b013e3181616c14.
PubMed 18379337
aan het Rot M, Collins KA, Murrough JW, Perez AM, Reich DL, Charney DS, Mathew SJ. Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):139-45. doi: 10.1016/j.biopsych.2009.08.038.
PubMed 19897179
Chen J, Peng LH, Luo J, Liu L, Lv F, Li P, Ao L, Hao XC, Min S. Effects of low-dose ketamine combined with propofol on phosphorylation of AMPA receptor GluR1 subunit and GABAA receptor in hippocampus of stressed rats receiving electroconvulsive shock. J ECT. 2015 Mar;31(1):50-6. doi: 10.1097/YCT.0000000000000148.
PubMed 24831997
Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
PubMed 10686270
Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
PubMed 16894061
Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. doi: 10.1016/j.biopsych.2009.04.029. Epub 2009 Jul 9.
PubMed 19545857
Ibrahim L, Diazgranados N, Luckenbaugh DA, Machado-Vieira R, Baumann J, Mallinger AG, Zarate CA Jr. Rapid decrease in depressive symptoms with an N-methyl-d-aspartate antagonist in ECT-resistant major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):1155-9. doi: 10.1016/j.pnpbp.2011.03.019. Epub 2011 Apr 3.
PubMed 21466832
McDaniel WW, Sahota AK, Vyas BV, Laguerta N, Hategan L, Oswald J. Ketamine appears associated with better word recall than etomidate after a course of 6 electroconvulsive therapies. J ECT. 2006 Jun;22(2):103-6. doi: 10.1097/00124509-200606000-00005.
PubMed 16801824
Krystal AD, Weiner RD, Dean MD, Lindahl VH, Tramontozzi LA 3rd, Falcone G, Coffey CE. Comparison of seizure duration, ictal EEG, and cognitive effects of ketamine and methohexital anesthesia with ECT. J Neuropsychiatry Clin Neurosci. 2003 Winter;15(1):27-34. doi: 10.1176/jnp.15.1.27.
PubMed 12556568
Kranaster L, Kammerer-Ciernioch J, Hoyer C, Sartorius A. Clinically favourable effects of ketamine as an anaesthetic for electroconvulsive therapy: a retrospective study. Eur Arch Psychiatry Clin Neurosci. 2011 Dec;261(8):575-82. doi: 10.1007/s00406-011-0205-7. Epub 2011 Mar 13.
PubMed 21400226
Wang X, Chen Y, Zhou X, Liu F, Zhang T, Zhang C. Effects of propofol and ketamine as combined anesthesia for electroconvulsive therapy in patients with depressive disorder. J ECT. 2012 Jun;28(2):128-32. doi: 10.1097/YCT.0b013e31824d1d02.
PubMed 22622291
Kellner CH, Briggs MC, Pasculli RM, Bryson EO. Antidepressant effect of the first electroconvulsive therapy with ketamine and/or propofol. J ECT. 2013 Jun;29(2):149. doi: 10.1097/YCT.0b013e3182702980. No abstract available.
PubMed 23703230

Want to know more?

Qibin Chen, Master

023-89011061

403497559@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy ---a Randomized Control Double-Blind Clinical Trial
ClinicalTrials.gov ID: NCT02305394
Acronym / sponsor ID: CYYYMZ-006
Conditions: Depressive Symptoms, Impaired Cognition, Electroconvulsive Therapy
Keywords: ketamine, Electroconvulsive Therapy, Cognitive Function
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 132 participants (estimated)
Lead sponsor: First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
Study start: Jan 2015
Primary completion: Dec 2016 (estimated)
Study completion: Feb 2017 (estimated)
First posted: 2 Dec 2014 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PK group (ketamine and propofol)	Experimental	Drug: ketamine and propofolpropofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.
P group (propofol group)	Active comparator	Drug: propofol and normal salinepropofol 1.5 mg/kg and normal saline [weight(kg)×0.3÷10]ml will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

diagnosed with moderate or severe depression according to Diagnostic and Statistical Manual of Mental Disorders
aged from 18 to 65 years old

Key exclusion criteria (11 listed)

cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;
classification of American Society of Anesthesiologists physical status score IV or V;
complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;
presence of a foreign body such as pacemaker, intracranial electrode, and clips;
history of seizures;

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 and propofolpropofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.	Drug	PK group (ketamine and propofol)
propofol and normal salinepropofol 1.5 mg/kg and normal saline [weight(kg)×0.3÷10]ml will be administered to participants separately by intravenous infusion.	Drug	P group (propofol group)

Primary outcome

Mini-Mental State examination score
Time frame: at 24 hours after the sixth ECT
Mini-Mental State examination score will be measured at 24 hours after the sixth ECT.

5 secondary outcomes

Mini-Mental State examination score
Time frame: at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.
Effects on Antidepression (Hamilton Depression Rating Scale(HDRS)
Time frame: at 24 hours before the first ECT and 24 hours after each ECT
Seizure Duration and Seizure Energy Index
Time frame: at 30 seconds after each ECT
Brief Psychiatric Rating Scale（BPRS）
Time frame: 60 minutes prior to the first ECT and at 40, 80, 110, and 230 minutes after each ECT
Adverse Effects include nausea, vomit, headache, tachycardia and increased blood pressure.
Time frame: at 40 minutes after each ECT

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
Background: PubMed 19397926Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.
Background: PubMed 17884272Garcia LS, Comim CM, Valvassori SS, Reus GZ, Barbosa LM, Andreazza AC, Stertz L, Fries GR, Gavioli EC, Kapczinski F, Quevedo J. Acute administration of ketamine induces antidepressant-like effects in the forced swimming test and increases BDNF levels in the rat hippocampus. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Jan 1;32(1):140-4. doi: 10.1016/j.pnpbp.2007.07.027. Epub 2007 Aug 8.
Background: PubMed 16429123Berton O, Nestler EJ. New approaches to antidepressant drug discovery: beyond monoamines. Nat Rev Neurosci. 2006 Feb;7(2):137-51. doi: 10.1038/nrn1846.
Background: PubMed 18379337Pigot M, Andrade C, Loo C. Pharmacological attenuation of electroconvulsive therapy--induced cognitive deficits: theoretical background and clinical findings. J ECT. 2008 Mar;24(1):57-67. doi: 10.1097/YCT.0b013e3181616c14.
Background: PubMed 19897179aan het Rot M, Collins KA, Murrough JW, Perez AM, Reich DL, Charney DS, Mathew SJ. Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):139-45. doi: 10.1016/j.biopsych.2009.08.038.
Background: PubMed 24831997Chen J, Peng LH, Luo J, Liu L, Lv F, Li P, Ao L, Hao XC, Min S. Effects of low-dose ketamine combined with propofol on phosphorylation of AMPA receptor GluR1 subunit and GABAA receptor in hippocampus of stressed rats receiving electroconvulsive shock. J ECT. 2015 Mar;31(1):50-6. doi: 10.1097/YCT.0000000000000148.
Background: PubMed 10686270Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
Background: PubMed 16894061Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
Background: PubMed 19545857Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. doi: 10.1016/j.biopsych.2009.04.029. Epub 2009 Jul 9.
Background: PubMed 21466832Ibrahim L, Diazgranados N, Luckenbaugh DA, Machado-Vieira R, Baumann J, Mallinger AG, Zarate CA Jr. Rapid decrease in depressive symptoms with an N-methyl-d-aspartate antagonist in ECT-resistant major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):1155-9. doi: 10.1016/j.pnpbp.2011.03.019. Epub 2011 Apr 3.
Background: PubMed 16801824McDaniel WW, Sahota AK, Vyas BV, Laguerta N, Hategan L, Oswald J. Ketamine appears associated with better word recall than etomidate after a course of 6 electroconvulsive therapies. J ECT. 2006 Jun;22(2):103-6. doi: 10.1097/00124509-200606000-00005.
Background: PubMed 12556568Krystal AD, Weiner RD, Dean MD, Lindahl VH, Tramontozzi LA 3rd, Falcone G, Coffey CE. Comparison of seizure duration, ictal EEG, and cognitive effects of ketamine and methohexital anesthesia with ECT. J Neuropsychiatry Clin Neurosci. 2003 Winter;15(1):27-34. doi: 10.1176/jnp.15.1.27.

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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.

Qibin Chen, Master contact

023-89011061

403497559@qq.com

Su Min principal investigator

First Affiliated Hospital of Chongqing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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: status not confirmed, as of the sponsor's last update on 2 Dec 2014. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qibin Chen, Master (023-89011061, 403497559@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mini-Mental State examination score (time frame: at 24 hours after the sixth ECT). 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 NCT02305394, which also lists 15 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 2 Dec 2014.