Major Depressive DisorderNCT01526395
Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital
A study testing Propofol in people with Major Depressive Disorder and Bipolar Disorder, run by Johns Hopkins University at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2011to Apr 2012
- 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
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Patients who are hemodynamically unstable or who have impaired cardiac function.
- BMI < 18.
- Patients with a history of epilepsy
Trial locations and contacts
1 site in 1 country.
India1 site
Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
Lucknow, Uttar Pradesh, 226003
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- Being tested
- Propofol
- Keywords
- electroconvulsive therapy, ECT, unmodified, anesthesia, propofol
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Unmodified ECT | No intervention | Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation. |
| Low Dose Propofol | Active comparator | Subjects will be given low dose propofol prior to ECT. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
Measured: 6 months
Secondary outcomes (8)
Rate at which ECT is offered and refused.
Measured: 6 months
Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.
Measured: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Inpatient length of stay calculated from onset of ECT administration.
Measured: 6 months
Number of ECTs required to complete a course of treatment
Measured: 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.
Measured: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Cognitive changes, monitored by the Mini Mental State Examination (MMSE)
Measured: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.
Measured: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).
Measured: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Chhatrapati Shahuji Maharaj Medical University
- Responsible party
- Principal investigator, Irving Reti, Johns Hopkins University
- Investigators
- Irving M Reti, MBBS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526395
- Sponsor's protocol ID
- NA_00027421
- Status last verified
- Apr 2013
- First submitted
- 21 Dec 2011
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing the Use of Unmodified ECT in an Indian Hospital
- ClinicalTrials.gov ID
- NCT01526395
- Acronym / sponsor ID
- NA_00027421
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- Keywords
- electroconvulsive therapy, ECT, unmodified, anesthesia, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Chhatrapati Shahuji Maharaj Medical University
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Feb 2012 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unmodified ECT | No intervention | –Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation. |
| Low Dose Propofol | Active comparator | Drug: PropofolSubjects will be given low dose propofol prior to ECT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| PropofolThe 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. | Drug | Low Dose Propofol |
Primary outcome
Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
Time frame: 6 months
8 secondary outcomes
Rate at which ECT is offered and refused.
Time frame: 6 months
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
Inpatient length of stay calculated from onset of ECT administration.
Time frame: 6 months
Number of ECTs required to complete a course of treatment
Time frame: 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
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
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
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
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 4 Apr 2013.
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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.
Irving M Reti, MBBS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Major Depressive Disorder and Bipolar Disorder, run by Johns Hopkins University at 1 site in India.
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 3 inclusion and 9 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 4 Apr 2013. 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 India. 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.
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?
Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2013.