NCT03915821

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

April 9, 2019

Last Update Submit

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

EXPERIMENTAL

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

Interventions

ECTDEVICE

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,

Patients diagnosed as major depression according to DSM V

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

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

Locations