Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

Kaiser Permanente

Status: Withdrawn

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

Treatments: Device: Brief Pulse Bitemporal; Device: Ultrabrief Right Unilateral

Study type: Interventional

Funder types: Other

Identifiers

NCT02238730

KPSC IRB 10133 (Other Identifier)

KPSC IRB10133

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Ultrabrief Right Unilateral

Active Comparator group

Description:

Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy

Treatment:

Device: Ultrabrief Right Unilateral

Brief Pulse Bitemporal

Active Comparator group

Description:

Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy

Treatment:

Device: Brief Pulse Bitemporal