Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02238730
• Other study ID #: KPSC IRB10133
• Secondary ID: KPSC IRB 10133
• Status: Withdrawn
• Phase: N/A
• First received: September 10, 2014
• Last updated: February 15, 2017
• Start date: September 2014
• Est. completion date: February 15, 2017

Study information

• Verified date: February 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Disease
• Major Depressive Disorder
• Treatment Resistant Depressive Disorder

Intervention

Device:
• Ultrabrief Right Unilateral
The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy
• Brief Pulse Bitemporal
The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HAMD)	Standardized assessment administered by a psychologist	up to 2-3 weeks
Secondary	Mini Mental Status Examination	Standardized assessment administered by a psychologist	up to 2-3 weeks