The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

NCT02066077 | Completed DMC

• 1 other identifier: SHDC12012109
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Modified Electroconvulsive Therapy; Cognition; Memory

Outcome Measures

Primary Outcomes (2)

• Change in Hamilton Depression Scale(HAMD) Scores

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

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

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

Secondary Outcomes (6)

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

  42d and 180d after the last MECT session

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

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

• Change in Hamilton Anxiety Scale(HAMA) Scores

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

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

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

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

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

Study Arms (7)

Bilateral temporal and propofol

EXPERIMENTAL

During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.

Drug: Propofol; Device: Bilateral temporal MECT

Bilateral temporal and etomidate

EXPERIMENTAL

During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.

Drug: Etomidate; Device: Bilateral temporal MECT

The right temporal and propofol

EXPERIMENTAL

During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.

Drug: Propofol; Device: The right temporal MECT

The right temporal and etomidate

EXPERIMENTAL

During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.

Drug: Etomidate; Device: The right temporal MECT

Bilateral frontal and propofol

EXPERIMENTAL

During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.

Drug: Propofol; Device: Bilateral frontal MECT

Bilateral frontal and etomidate

EXPERIMENTAL

During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.

Drug: Etomidate; Device: Bilateral frontal MECT

Standard-therapy Group

ACTIVE COMPARATOR

During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.

Drug: Etomidate; Device: Bilateral temporal MECT

Interventions

Etomidate DRUG

Bilateral frontal and etomidate; Bilateral temporal and etomidate; Standard-therapy Group; The right temporal and etomidate

Propofol DRUG

Bilateral frontal and propofol; Bilateral temporal and propofol; The right temporal and propofol

Bilateral temporal MECT DEVICE

Bilateral temporal and etomidate; Bilateral temporal and propofol; Standard-therapy Group

The right temporal MECT DEVICE

The right temporal and etomidate; The right temporal and propofol

Bilateral frontal MECT DEVICE

Bilateral frontal and etomidate; Bilateral frontal and propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Tongji Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Etomidate; Propofol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 19, 2014
• Study Start: January 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 23, 2018

Record last verified: 2017-12

Locations

CN (1)