Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

Not Applicable

Withdrawn

• Conditions: Depressive Disorder; Treatment Resistant Depressive Disorder; Bipolar Disorder; Major Depressive Disorder; Depression
• Interventions: Device: Ultrabrief Right Unilateral; Device: Brief Pulse Bitemporal

• Registration Number: NCT02238730
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Status Verified: 2017-02
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrabrief Right Unilateral	Ultrabrief Right Unilateral	Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy
Brief Pulse Bitemporal	Brief Pulse Bitemporal	Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD)	up to 2-3 weeks	Standardized assessment administered by a psychologist

Secondary Outcome Measures

Name	Time	Method
Mini Mental Status Examination	up to 2-3 weeks	Standardized assessment administered by a psychologist