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Completed

NCT Number: NCT03915821

Memory Changes in Patients With Major Depression Disorder Treated With ECT

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

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuropsychiatry & Neurosurgery Hospital

Asyut, Asyut Governorate, 71511, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

ECT

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,

Primary outcomes

  1. 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 .

    Time frame: Baseline

    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.

  2. 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

    Time frame: Baseline

    • 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 .

  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

    Time frame: Baseline

    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 .

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 16, 2019
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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