Memory Changes in Patients With Major Depression Disorder Treated With ECT

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915821
• Other study ID #: Memory Changes with ECT
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2022
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

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,

Locations

Country	Name	City	State
Egypt	Neuropsychiatry & Neurosurgery Hospital	Asyut	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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