Memory Changes in Patients With Major Depression Disorder Treated With ECT
1 other identifier
interventional
60
1 country
1
Brief Summary
The basic memory changes (impairment) present in patients with major depression and the influence of the treatment with ECT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
1 active site
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
First Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedJuly 5, 2023
July 1, 2023
6 months
April 9, 2019
July 1, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
Patients diagnosed as major depression according to DSM V
EXPERIMENTALAll 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.
Interventions
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,
Eligibility Criteria
You may qualify if:
- Patients diagnosed as having major depression according to DSM V.
- Patients aged (18-50 years) of both sexes.
You may not qualify if:
- History or current evidence of systemic medical illness, e.g.: hepatic, renal, cardiovascular, endocrinal, metabolic disorders or others.
- History or current evidence of any Neurological disease.
- Pregnant females.
- Co-morbid psychiatric disorders other than depression.
- Patients with mental subnormality.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neuropsychiatry & Neurosurgery Hospital
Asyut, Asyut Governorate, 71511, Egypt
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Doctor
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 16, 2019
Study Start
December 15, 2020
Primary Completion
June 15, 2021
Study Completion
March 30, 2022
Last Updated
July 5, 2023
Record last verified: 2023-07