Memory Changes in Patients With Major Depression Disorder Treated With ECT

Memory Changes in Patients With Major Depression Disorder Treated With Electroconvulsive Therapy

The basic memory changes (impairment) present in patients with major depression and the influence of the treatment with ECT.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder
• Intervention / Treatment: Device: ECT

Detailed Description

Current literature provides insufficient information on the degree of cognitive impairment during and after electroconvulsive therapy (ECT), mostly due to the fact that applied tests lacked sensitivity and flexibility. Our goal was to evaluate cognitive functioning in adult depressed patients treated with bi & uni lateral & ECT, using tests sensitive for detection of possible acute and medium-term memory changes.(9) Major depressive disorder (MDD) is estimated to affect around 16 million Americans (Substance Abuse and Mental Health Services Administration [SAMHSA], 2013) and, according to the World Health Organization, is the leading cause of disability worldwide (World Health Organization 2012). Among In the U.S. workforce, the prevalence of MDD has been estimated at 7.6% .(2) Electroconvulsive therapy (ECT) is an effective treatment for severe depression but entails cognitive adverse effects, particularly the effects on memory. ECT may cause a temporary deficit in the cognitive processes of information encoding, consolidation, and retrieval. Transient memory disturbances are regarded as an inevitable adverse effect of therapeutic convulsions. Various strategies have been tried to decrease the cognitive adverse effects while retaining the antidepressant effect, including the use of unilateral instead of bilateral electrode placement, changes in waveform, and reducing the electrical stimulus intensity, (4).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman Nabiel Abd-Elhakeem, M.B.B.Ch; Phone Number: 01006123163; Email: aymannabiel@yahoo.com
• Study Contact Backup: Name: Alaa-Eldin Mo Darweesh, Supervisor; Phone Number: 01005279326; Email: Assiutbird25@yahoo.com

Study Locations

• Egypt
  • Asyut
    • Asyūţ, Asyut, Egypt, 71511
      • Neuropsychiatry & Neurosurgery Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients diagnosed as having major depression according to DSM V.
2. Patients aged (18-50 years) of both sexes.

Exclusion Criteria:

1. History or current evidence of systemic medical illness, e.g.: hepatic, renal, cardiovascular, endocrinal, metabolic disorders or others.
2. History or current evidence of any Neurological disease.
3. Pregnant females.
4. Co-morbid psychiatric disorders other than depression.
5. Patients with mental subnormality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients diagnosed as major depression according to DSM V; All patients presented with major depression disorder not received ECT previously within 6 monthes, admitted to the study site ( Psychiatry department, in Assiut University Hospital, Assiut, Egypt). They Fulifilled will be recruited within 6 monthes duration . The patients classified into group A comprised that will be treated with Unipolar ECT, and group B comprised that will be treated Biploar ECT.

Device: ECT; Electroconvulsive therapy was administered by using bidirectional constant current, brief-pulse devices. During the procedure, the patients were sedated using propofol or thiopenthal. Succinylcholine (1 mg/kg) was used as muscle relaxant, and glycopyrrolate (0.2 mg) or atropine was used as an anticholinergic agent when necessary. The mean charges were 351 (SD, 143) mC for the unilateral electrode placement group, 417 (SD, 192) mC for the bitemporal electrode placement group and 260 (SD, 76) mC for the bifrontal electrode placement group, (Brus, Ole MSc, 2017). The average course of treatment for depression is 6 to 12 treatments, but some patients may require as many as 20 treatments,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the subjective memory changes present in a sample of patients with major depression disorder who admitted to psychiatry unit and evaluation of memory changes following ECT treatment .	Reach the least level of side effects in memory of Recent treatment with ECT in patient with major depression. measurement tool: _ History taking and full general & neurological examination to exclude any neurological disease.; Minim Mental State Examination, (MMSE) (Appendix I); All Scales will be taken at date of admission, and at discharge up to 15 days and after three months of discharge .All patients will be subjected to full psychiatric history and examination. The results of the above mentioned laboratory, investigations will be included in future analysis and interpretation of patients' abnormal psychiatric findings.	Baseline
Evaluate the subjective memory changes present in a sample of patients with major depression disorder who admitted to psychiatry unit and evaluation of memory changes following ECT treatment	Hamiliton rate Scale for depression,(HAM-D) (Appendix II),before and after treatment with ECT.; All Scales will be taken at date of admission,and at discharge up to 15 days and after three months of discharge .	Baseline
Evaluate the subjective memory changes present in a sample of patients with major depression disorder who admitted to psychiatry unit and evaluation of memory changes following ECT treatment	Memory scale (MONTREAL COGNITIVE ASSESSMENT. MOCA), (Appendix III) All Scales will be taken at date of admission,and at discharge up to 15 days and after three months of discharge .	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 1-American Psychiatric Association, Review; 2018 (http://www.aetna.com/cpb/medical/data/400_499/0445.htm). 2-Birnbaum, H. G., et, al,. (2010). Employer burden of mild, moderate, and severe major depressive disorder: Mental health services utilization and costs, and work performance. J Clin Psychiatry.27: 78-89. 3-Brus, et al Subjective Memory Immediately Following Electroconvulsive Therapy. The Journal of ECT: June 2017 - 33 : 2 - 96-103. 4-Brus, et, al, (2017) Subjective Memory Immediately Following Electroconvulsive ; Therapy, The Journal of ECT: June 33 : 2 - 96-103 5-Greenberg, et al, (2015). The economic burden of adults with major depressive disorder in the United States (2005 and 2010). Journal of Clinical Psychiatry, 76: 155-162. 6-Kessler, R. C. (2012). The costs of depression. Psychiatric Clinic of North America, 35:1-14. 7-Philip S. Wang Gregory Simon Ronald C. Kessler First published: 24 March 2006, https://doi.org/10.1002/mpr.139. 8-UK ECT Review Group (2003). Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet. 2003- 361:799-808. 9-N. P. Maric: et,al, psychological medicine Volume 46, Issue 4 March 2016 , pp. 797-806

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 14, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: Memory Changes with ECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No