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Completed

NCT Number: NCT02066077

The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

1. To determine the influencing factors of modified electroconvulsive therapy (MECT); 2. To determine the influencing factors and reversibility of the cognitive impairment caused by MECT; 3. To determine the duration of efficacy of MECT and its affecting factors.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged over 18 years (when informed consent was got), male or female
  • Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression
  • Scored 18 or above on the HAM-D Scale which included 17 items
  • Clinical Global Impression(CGI)-severity score ≥ 4
  • Provided written informed consent

Exclusion criteria

  • Any depressive disorders not due to major depressive disorder
  • Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I
  • With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy
  • With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants
  • With a history of severe or unstable physical disease including nervous system disease and myocardial infarction
  • Undergoing alcoholism or alcohol (or substance) abuse during 30 days or 6 months before the trial
  • With no response to previous ECT treatment
  • Received transcranial magnetic stimulation treatment in the last 6 months
  • Allergic to propofol, etomidate and succinylcholine chloride
  • During pregnancy or lactation
  • With a history of stroke in the last month
  • Enrolled in any other clinical trial 30 days prior to the baseline

Treatment and study plan

Etomidate

Drug

Propofol

Drug

Bilateral temporal MECT

Device

The right temporal MECT

Device

Bilateral frontal MECT

Device

Primary outcomes

  1. Change in Hamilton Depression Scale(HAMD) Scores

    Time frame: Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session

  2. Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety

    Time frame: Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session

Secondary outcomes

  1. Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State

    Time frame: 42d and 180d after the last MECT session

  2. Resting-state/Task-state functional magnetic resonance imaging (fMRI)

    Time frame: Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session

  3. Change in Hamilton Anxiety Scale(HAMA) Scores

    Time frame: Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session

  4. Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy

    Time frame: Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session

  5. Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety

    Time frame: Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session

  6. Change in P300/P50 Event-Related Potentials(ERP)

    Time frame: Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • Huashan Hospital
  • Tongji Hospital

Registry information

Official study title

The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2014
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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