Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Depressive Disorder; Depression; Bipolar Disorder; Major Depressive Disorder; Treatment Resistant Depressive Disorder
• Intervention / Treatment: Device: Ultrabrief Right Unilateral; Device: Brief Pulse Bitemporal

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. Major Depressive Disorder, Single Episode
  2. Major Depressive Disorder, Recurrent
  3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Ronad L Warnell, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 15, 2017

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Bipolar Disorder; Depressive Disorder; Major Depressive Disorder; Electroconvulsive therapy; Treatment Resistant Depressive Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Disease; Bipolar Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: KPSC IRB10133; KPSC IRB 10133 (Other Identifier: Kaiser Permanente Southern California IRB)