Protocol summary
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Study aim
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Determining the effect of Lemon Balm Capsule on Cognitive Disorders in Depressed Patients treated with ECT
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Design
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Sampling will first be done in an accessible way that all hospitalized patients who met the study conditions will be included in the study. Random allocation of people to two groups will be done by randomization of permutation blocks and using software, random allocation
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Settings and conduct
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Necessary referral letters will be provided to the psychiatric ward of Hajar Hospital and after sampling through random allocation, they will be placed in intervention and control groups.The Study is a Blind One-Way study in which data analysts do not know about the drug used
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Participants/Inclusion and exclusion criteria
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Participants in this study were 80 patients treated with ECT
Inclusion Criteria: The age range of patients is 18-65 years; their Major Depressive Disorder has been confirmed by a psychiatrists; the patient has no history of allergy to the mint family; lack of physical illness leading to Cognitive Impairment such as Head Trauma, Dementia, Retardation-Mental Retardation and Epilepsy; patients receiving SSRIs (according to a psychiatrist).
Exclusion Criteria: Patients who have other Mental Disorders in addition to Depression; reluctance to continue cooperation before the end of the project; occurrence of stressful events affecting the Patient's mood during the implementation of the plan; use of other Antidepressants Drugs (except SSRIs)
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Intervention groups
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The two groups of 40 people, including the intervention and control groups, will use 500 mg of Lemon Balm capsules in the intervention group and 500mg of starch capsules in the control group.
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Main outcome variables
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ImprovesPost-ECT Amnesia
General information
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Reason for update
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Increasing the number of samples
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180613040083N1
Registration date:
2022-06-10, 1401/03/20
Registration timing:
prospective
Last update:
2022-10-07, 1401/07/15
Update count:
2
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Registration date
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2022-06-10, 1401/03/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-22, 1401/07/30
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Expected recruitment end date
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2022-11-21, 1401/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the Effect of Melissa Officinalis L ( Lemon Balm) Capsule on Cognitive Impairment in Depressed Patients Treated With ECT
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Public title
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Evaluation of the Effect of Melissa Officinalis L ( Lemon Balm) Capsule on Cognitive Impairment in Depressed Patients Treated With ECT
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The age range of patients is 18-65 years.
Their Major Depressive Disorder has been confirmed by a psychiatrist
The patient has no history of allergy to The mint family.
Lack of physical illness leading to Cognitive Impairment such as Head Trauma, Dementia, Retardation - Mental Retardation And EpilepsyPatients
Receiving SSRIs (according to a psychiatrist).
Exclusion criteria:
Patients who have other Mental Misorders in addition to Depression..
Reluctance to continue cooperation before The end of the project
Occurrence of stressful events affecting The patient's mood during the implementation of The plan
Use of other Antidepressants Drugs(except SSRIs)
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To randomly assign individuals to two groups, using the randomization Replacement blocks method were used. By using the software, a random block of fifteen blocks with a volume of six was designed and a randomization list was provided to the researchers. In each of the 70 blocks are written two letters, a, two letters b, a which means intervention group and b means control group
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study is a double-blind study, in which the project implementer and the patients are not aware of the process and drugs, and the data analyst is not aware of the drug used.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-08, 1400/03/18
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Ethics committee reference number
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IR.SKUMS.REC.1400.074
Health conditions studied
1
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Description of health condition studied
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Major Depression , ECT
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ICD-10 code
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F99
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ICD-10 code description
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Mental disorder, Not Otherwise Specified
Primary outcomes
1
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Description
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Cognitive Disorders Score in Cognitive Status Assessment Questionnaire (MMSE Questionnaire)
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Timepoint
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Measurement of Cognitive Disorders before intervention and one month after consumption of Lemon Balm Capsules
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Method of measurement
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Cognitive Status Assessment Questionnaire (MMSE Questionnaire)
Intervention groups
1
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Description
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Intervention group: 40 depressed patients treated with ECT, receiving 500mg lemon balm capsules (made by the Made by a pharmacologist) every 8 hours after a month Evaluation with questionnaire
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Category
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Treatment - Drugs
2
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Description
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Control Group: 40 depressed patients treated with ECT, receiving 500mg placebo capsules (made by the Made by a pharmacologist) every 8 hours after a month Evaluation with questionnaire
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahre-kord University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available