Memory Changes in Patients With Major Depression Disorder Treated With ECT

NCT ID: NCT03915821

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-03-30

Brief Summary

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

Conditions

Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ECT

Intervention Type: DEVICE

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,

Interventions

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,

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Nabiel Abd-Elhakeem Metawlly

Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neuropsychiatry & Neurosurgery Hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

References

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

Reference Type: BACKGROUND

Other Identifiers

Memory Changes with ECT

Identifier Type: -

Identifier Source: org_study_id