Clinical trial NCT01526395: Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital
Official title: Decreasing the Use of Unmodified ECT in an Indian Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Bipolar Disorder
Schizophrenia
Keywords: electroconvulsive therapy
ECT
unmodified
anesthesia
propofol
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Bloomberg School of Public Health
name: Chhatrapati Shahuji Maharaj Medical University
First posted: 2012-02-03
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
timeFrame: 6 months
Secondary outcomes:
measure: Rate at which ECT is offered and refused.
timeFrame: 6 months
measure: Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.
timeFrame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
measure: Inpatient length of stay calculated from onset of ECT administration.
timeFrame: 6 months
measure: Number of ECTs required to complete a course of treatment
timeFrame: 6 months
measure: 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.
timeFrame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
measure: Cognitive changes, monitored by the Mini Mental State Examination (MMSE)
timeFrame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
measure: Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.
timeFrame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
measure: Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).
timeFrame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
state: Uttar Pradesh
Study officials:
affiliation: Johns Hopkins University
name: Irving M Reti, MBBS
role: PRINCIPAL_INVESTIGATOR
References: