Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital

Schizophrenia Clinical Trial

Official title:

Decreasing the Use of Unmodified ECT in an Indian Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526395
• Other study ID #: NA_00027421
• Status: Completed
• Phase: N/A
• First received: December 21, 2011
• Last updated: April 1, 2013
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical 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. & 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Schizophrenia

Intervention

Drug:
• Propofol
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.

Locations

Country	Name	City	State
India	Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals	Lucknow	Uttar Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Chhatrapati Shahuji Maharaj Medical University, Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.		6 months	No
Secondary	Rate at which ECT is offered and refused.		6 months	No
Secondary	Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.		Baseline and completion of ECT treatments or up to 6 months, whichever comes first	No
Secondary	Inpatient length of stay calculated from onset of ECT administration.		6 months	No
Secondary	Number of ECTs required to complete a course of treatment		6 months	No
Secondary	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.		Baseline and completion of ECT treatments or up to 6 months, whichever comes first	No
Secondary	Cognitive changes, monitored by the Mini Mental State Examination (MMSE)		Baseline and completion of ECT treatments or up to 6 months, whichever comes first	No
Secondary	Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.		Baseline and completion of ECT treatments or up to 6 months, whichever comes first	Yes
Secondary	Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).		Baseline and completion of ECT treatments or up to 6 months, whichever comes first	Yes