Clinical trial NCT02305394: Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depressive Symptoms
Impaired Cognition
Electroconvulsive Therapy
Keywords: ketamine
Electroconvulsive Therapy
Cognitive Function
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;
2. classification of American Society of Anesthesiologists physical status score IV or V;
3. complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;
4. presence of a foreign body such as pacemaker, intracranial electrode, and clips;
5. history of seizures;
6. history of drug abuse;
7. concomitant presence of a mental disorder;
8. pregnancy;
9. history of serious adverse effects related to anesthetics;
10. refusal to consent for the study, or refusal to undergo one single ECT during the first week of therapy.
11. hyperthyreosis

Primary outcomes:
measure: Mini-Mental State examination score
timeFrame: at 24 hours after the sixth ECT
Secondary outcomes:
measure: Mini-Mental State examination score
timeFrame: at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.
measure: Effects on Antidepression (Hamilton Depression Rating Scale(HDRS)
timeFrame: at 24 hours before the first ECT and 24 hours after each ECT
measure: Seizure Duration and Seizure Energy Index
timeFrame: at 30 seconds after each ECT
measure: Brief Psychiatric Rating Scale（BPRS）
timeFrame: 60 minutes prior to the first ECT and at 40, 80, 110, and 230 minutes after each ECT
measure: Adverse Effects include nausea, vomit, headache, tachycardia and increased blood pressure.
timeFrame: at 40 minutes after each ECT
Other outcomes:
Locations:
city: Chongqing
country: China
facility: China,Chongqing The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Su Min
role: PRINCIPAL_INVESTIGATOR
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