NCT02238730

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Typical duration for not_applicable depression

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

September 10, 2014

Last Update Submit

February 15, 2017

Conditions

DepressionDepressive DisorderTreatment Resistant Depressive DisorderBipolar DisorderMajor Depressive Disorder

Keywords

DepressionDepressive DisorderTreatment Resistant Depressive DisorderBipolar DisorderMajor Depressive DisorderElectroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale (HAMD)

    Standardized assessment administered by a psychologist

    up to 2-3 weeks

Secondary Outcomes (1)

  • Mini Mental Status Examination

    up to 2-3 weeks

Study Arms (2)

Ultrabrief Right Unilateral

ACTIVE COMPARATOR

Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy

Device: Ultrabrief Right Unilateral

Brief Pulse Bitemporal

ACTIVE COMPARATOR

Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy

Device: Brief Pulse Bitemporal

Interventions

Ultrabrief Right UnilateralDEVICE

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

Also known as: Thymatron System IV
Ultrabrief Right Unilateral
Brief Pulse BitemporalDEVICE

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

Also known as: Thymatron System IV
Brief Pulse Bitemporal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Major Depressive Disorder, Single Episode
  • Major Depressive Disorder, Recurrent
  • Bipolar Disorder, Currently Depressed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionDepressive DisorderDepressive Disorder, Treatment-ResistantBipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental DisordersBipolar and Related Disorders

Study Officials

  • Ronad L Warnell, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 12, 2014

Study Start

September 1, 2014

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

February 17, 2017

Record last verified: 2017-02