- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01526395
Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital
April 1, 2013 updated by: Irving Reti, Johns Hopkins University
Decreasing the Use of Unmodified ECT in an Indian Hospital
In developing countries, electroconvulsive therapy (ECT) is typically delivered without the use of an anesthetic prior to the treatment, known as unmodified ECT.
This interventional study aims to decrease the practice of unmodified ECT at Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals (C.S.M) by administering a low dose anesthetic (propofol) prior to ECT delivery.
In so doing, the investigators hope to facilitate the transition from unmodified to modified ECT without incurring excessive costs to the center.
It is hypothesized that ECT patients will opt for modified treatment, that adverse effects will be minimal, and that costs will not rise prohibitively.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients that are currently receiving unmodified ECT at C.S.M Hospital will be eligible for the first phase of the study in which only data is collected.
Three months after study start, patients who are to receive ECT for a psychiatric disorder will be eligible to participate in the intervention (introduction of propofol at a low dose prior to ECT).
Data collection will include information such as demographics, ratings scales, seizure length, anxiety level, adverse events, and number of treatments.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
- Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects are any psychiatric patients at C.S.M. for whom ECT is recommended by their doctor, whether or not they actually receive ECT.
- Subjects must also have an American Society for Anesthesiologists (ASA) rating score of 1 (completely healthy) or 2 (mild systemic disease) with stable symptoms and laboratory values.
- Subjects must be between the ages of 18 to 65 years old and be able to give informed consent.
Exclusion Criteria:
- Patients who speak neither English nor Hindi.
- History of or anatomical evidence for a difficult airway being a short mandible, micrognathia, large tongue or large goiter, arthritis of the jaw or neck, or enlarged tonsils. For this reason we will also exclude patients with a BMI > 28.
- Respiratory tract disease including asthma, respiratory infection, chest wall disease, chronic obstructive pulmonary disease, obstructive sleep apnea, or other disorder which might compromise the airway. Patients who smoke 15 or more cigarettes per day will be excluded unless abstinent for at least 10 days, to reduce the risk of respiratory complications.
- Patients who receive modified ECT during the first phase of the study.
- Pregnant women or women who are breastfeeding.
- Hypersensitivity to propofol or any of its components.
- Patients who are hemodynamically unstable or who have impaired cardiac function.
- BMI < 18.
- Patients with a history of epilepsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Unmodified ECT
Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation.
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Active Comparator: Low Dose Propofol
Subjects will be given low dose propofol prior to ECT.
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The major intervention proposed in this study is the introduction of low dose IV propofol for sedation prior to ECT treatment at C.S.M Medical University.
The investigators will use a dose of 0.25 to 0.50 mg/kg of IV propofol.
The maximum dose of 0.50 mg/kg is not sufficient for anesthesia (i.e., to make unconscious), but should provide a light level of sedation and be "amnestic," meaning the patient should have memory loss for the period of time around the ECT procedure itself.
The propofol dose will be titrated upwards (from an initial dose of 0.25 mg/kg) with successive treatments in increments of 0.05mg/kg, until it is just sufficient to be lightly sedating.
ECT will be administered 30 to 60 seconds after propofol is injected.
ECT may be given up to three times per week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate at which ECT is offered and refused.
Time Frame: 6 months
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6 months
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Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.
Time Frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Inpatient length of stay calculated from onset of ECT administration.
Time Frame: 6 months
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6 months
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Number of ECTs required to complete a course of treatment
Time Frame: 6 months
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6 months
|
Changes in scales used to assess severity of symptoms. The investigators will record changes in the Hamilton Depression Rating Scale, the Young Mania Rating Scale, the Brief Psychiatric Rating Scale and the Clinical Global Impression Severity scale.
Time Frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Cognitive changes, monitored by the Mini Mental State Examination (MMSE)
Time Frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.
Time Frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).
Time Frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Irving M Reti, MBBS, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
December 21, 2011
First Submitted That Met QC Criteria
February 1, 2012
First Posted (Estimate)
February 3, 2012
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 1, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
- Depressive Disorder
- Schizophrenia
- Disease
- Bipolar Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Hypnotics and Sedatives
- Propofol
Other Study ID Numbers
- NA_00027421
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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