Protocol summary
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Study aim
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Studying the effect of Sulforaphane on the treatment of mild to moderate depression in post percutaneous coronary intervention patients
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Design
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Randomized double blind and placebo-controlled clinical trial
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Settings and conduct
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The study will be performed on patients with heart disease who underwent percutaneous coronary intervention, and with mild to moderate depression attending Roozbeh Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: based on DSM-5 diagnostic criteria, have minor depression disorder; based on Hamilton depression scale, get the score of 14 to 17; age between 18 to 50 years old; history of percutaneous coronary intervention. Exclusion criteria: pregnant or lactating women; presence of other psychiatric disorders; be psychotic; history of Electroconvulsive therapy; two months prior to the trial; using psychotropic drug; drug addiction; presence of thyroid disease.
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Intervention groups
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Patients with mild to moderate depression (based on DSM-5 diagnostic criteria) are included in the study and divided into two control (25 participants) and intervention (25 participants) groups. Patients in the intervention group receive Sulforaphane tablet for 6 weeks, and patients in the control group receive placebo for 6 weeks. Patients are assessed at weeks 0, 2, 4, and 6 by Hamilton depression scale. Side effects of the drug are assessed at weeks 1, 2, 4 and 6.
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Main outcome variables
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Severity of depression
General information
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Reason for update
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We have to find older patients
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090117001556N128
Registration date:
2020-05-19, 1399/02/30
Registration timing:
prospective
Last update:
2021-01-02, 1399/10/13
Update count:
1
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Registration date
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2020-05-19, 1399/02/30
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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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2020-06-21, 1399/04/01
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Expected recruitment end date
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2022-06-22, 1401/04/01
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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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Sulforaphane as a treatment for mild to moderate depression in post percutaneous coronary intervention patients: A randomized double blind and placebo controlled clinical trial
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Public title
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The effect of Sulforaphane on the treatment of mild to moderate depression in post percutaneous coronary intervention patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Based on DSM-5 diagnostic criteria, have minor depression disorder
Based on Hamilton depression scale, get the score of 14 to 17
Age between 40 to 65 years
History of percutaneous coronary intervention
Exclusion criteria:
Pregnant or lactating women
Presence of other psychiatric disorders
Be psychotic
History of Electroconvulsive therapy, two months prior to the trial
Using psychotropic drug
Drug addiction
Presence of Thyroid disease
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Age
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From 40 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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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups)
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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 participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
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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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2019-12-22, 1398/10/01
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.1004
Health conditions studied
1
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Description of health condition studied
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Depression
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ICD-10 code
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F32.1
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ICD-10 code description
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Major depressive disorder, single episode, moderate
Primary outcomes
1
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Description
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Severity of depression
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Timepoint
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Baseline and weeks 2, 4, and 6
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Method of measurement
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By Hamilton depression scale
Intervention groups
1
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Description
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Intervention group: Sulforaphane tablet (ACECR, Tehran), 30 mg per day for 6 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, once a day for 6 weeks
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Category
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Placebo
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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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data will be distributed through final report
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When the data will become available and for how long
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5 years from 2021 to 2026
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To whom data/document is available
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academic researchers
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Under which criteria data/document could be used
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users should cite the resource of data
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From where data/document is obtainable
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Prof Shahin Akhondzadeh
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What processes are involved for a request to access data/document
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by E mail
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Comments
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