Depressive DisorderNCT03915821
Memory Changes in Patients With Major Depression Disorder Treated With ECT
A study testing ECT in people with Depressive Disorder, run by Assiut University at 1 site in Egypt.
Trial summary
The basic memory changes (impairment) present in patients with major depression and the influence of the treatment with ECT. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- ECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed as having major depression according to DSM V.
- Patients aged (18-50 years) of both sexes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neuropsychiatry & Neurosurgery Hospital
Asyut, Asyut Governorate, 71511
About this study
Official title: Memory Changes in Patients With Major Depression Disorder Treated With Electroconvulsive Therapy
The basic memory changes (impairment) present in patients with major depression and the influence of the treatment with ECT.
Read the 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
- Being tested
- ECT
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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 .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 Dec 2020
- Primary completion15 Jun 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Nabiel Abd-Elhakeem Metawlly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915821
- Sponsor's protocol ID
- Memory Changes with ECT
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2019
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Changes in Patients With Major Depression Disorder Treated With Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT03915821
- Acronym / sponsor ID
- Memory Changes with ECT
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed as major depression according to DSM V | Experimental | Device: ECTAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed as having major depression according to DSM V.
- Patients aged (18-50 years) of both sexes.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECTElectroconvulsive 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, | Device | Patients diagnosed as major depression according to DSM V |
Primary outcome
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.
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 .
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background1-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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECT in people with Depressive Disorder, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03915821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.