Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

Study Overview
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Brief Summary
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To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.

Detailed Description
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Patients will be randomized to either bitemporal brief pulse electroconvulsive therapy ( 0.5 ms pulse width) or right unilateral ultrabrief pulse electroconvulsive therapy for the first six treatments. If further treatment is necessary, electrode placement will be chosen by the treating psychiatrist. All electroconvulsive therapy treatments will be performed with a Thymatron System IV instrument. (Somatics, LLC, Lake Bluff, Illinois, USA) Pre- electroconvulsive therapy testing will occur within one week of beginning treatment. Post-electroconvulsive therapy testing will occur within 48 hours of the 6th treatment.

Official Title
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Comparative Efficacy and Cognitive Side-Effects of Ultrabrief Right Unilateral Electroconvulsive Therapy and Brief Pulse Bitemporal Electroconvulsive Therapy

Conditions
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Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder

Intervention / Treatment
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* Device: Ultrabrief Right Unilateral
* Device: Brief Pulse Bitemporal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients age 18 and above referred for electroconvulsive therapy will be screened for eligibility for participation in this study. Basic competency in English Diagnosis of either of the following: Major Depressive Disorder, Single Episode Major Depressive Disorder, Recurrent Bipolar Disorder, Currently Depressed Exclusion Criteria: Pre-existing cognitive impairment with an initial Mini Mental Status Exam Score of 24 or lower Major neurological disease Other medical conditions making electroconvulsive therapy an excessive risk to be completed safely in an outpatient surgery center and anticonvulsant therapy. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrabrief Right Unilateral<br>Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy | Device: Ultrabrief Right Unilateral<br>* The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy<br>* Other names: Thymatron System IV;|
| Active Comparator: Brief Pulse Bitemporal<br>Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy | Device: Brief Pulse Bitemporal<br>* The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy<br>* Other names: Thymatron System IV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAMD) | Standardized assessment administered by a psychologist | up to 2-3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental Status Examination | Standardized assessment administered by a psychologist | up to 2-3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder, Electroconvulsive therapy