Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

NCT ID: NCT02238730

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-02-15

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.

Conditions

Depression; Depressive Disorder; Treatment Resistant Depressive Disorder; Bipolar Disorder; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ultrabrief Right Unilateral

Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy

Group Type: ACTIVE_COMPARATOR

Ultrabrief Right Unilateral

Intervention Type: DEVICE

The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy

Brief Pulse Bitemporal

Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy

Group Type: ACTIVE_COMPARATOR

Brief Pulse Bitemporal

Intervention Type: DEVICE

The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy

Interventions

Ultrabrief Right Unilateral

The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy

Intervention Type: DEVICE

Brief Pulse Bitemporal

The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy

Intervention Type: DEVICE

Other Intervention Names

Thymatron System IV; Thymatron System IV

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronad L Warnell, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Other Identifiers

KPSC IRB 10133

Identifier Type: OTHER

Identifier Source: secondary_id

KPSC IRB10133

Identifier Type: -

Identifier Source: org_study_id