Protocol summary
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Study aim
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Study of therapeutic effects of Atomoxtein in reducing the incidence of symptoms in patients with recurrent vasovagal syncope
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Design
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This study is a double-blind placebo-controlled randomized clinical trial.
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Settings and conduct
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In this study, patients will be recruited from referrals to the specialized syncope clinic of Tehran Heart Center. Eligible participants will be randomized to 2 parallel groups with a 1:1 ratio: 1) Standard treatment plus atomoxetine. 2) Standard treatment plus identical-looking placebo. Medications will be given to patients in sequentially numbered opaque sealed envelopes. This is a double-blind randomized clinical trial in which the patients and the investigators will be blinded to the randomized intervention. Follow-up visits will be done on month 1 and 3.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients who come to the Tehran Heart Center with a complaint of syncope or pre-syncope with the clinical diagnosis of vasovagal syncope or have undergone tilt test, if needed, and experienced at least 3 syncopal episodes in the past 3 months.
Exclusion criteria:
Age under 10 or over 70 years old
History of uncontrolled blood pressure
History of structural heart disease
History of epilepsy
History of closed angle glaucoma
History of diabetes mellitus
History of coronary artery disease
Ejection fraction < 50%
Use of monoamine oxidase inhibitors (MAOIs)
Use of selective serotonin reuptake inhibitors (SSRIs)
Use of anticonvulsants
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Intervention groups
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Intervention group: Administration of Atomoxetine with a dose of 20 mg per day for 2 weeks and 40 mg per day for another 2 weeks if tolerated
Control group: Receive placebo with the above command
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Main outcome variables
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The number of (pre-)syncopal episodes on month 1 and 3.
General information
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Reason for update
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Completion and modification of the protocol of the study according to the setting of the recruitment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180125038507N1
Registration date:
2018-08-03, 1397/05/12
Registration timing:
registered_while_recruiting
Last update:
2019-12-24, 1398/10/03
Update count:
1
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Registration date
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2018-08-03, 1397/05/12
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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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2018-07-23, 1397/05/01
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Expected recruitment end date
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2019-07-23, 1398/05/01
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Actual recruitment start date
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2018-07-25, 1397/05/03
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Actual recruitment end date
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2019-07-23, 1398/05/01
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Trial completion date
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2019-10-23, 1398/08/01
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Scientific title
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Study of the therapeutic effects of Atomoxetine in comparison with placebo on reducing the incidence of symptoms in patients with recurrent vasovagal syncope;
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Public title
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Study of therapeutic effects of Atomoxtein in reducing the symptoms of patients with recurrent vasovagal syncope
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who come to the Tehran Heart Center with a complaint of syncope or pre-syncope with the clinical diagnosis of vasovagal syncope or have undergone tilt test, if needed, and experienced at least 3 syncopal episodes in the past 3 months.
Exclusion criteria:
Age under 10 or over 70 years old
History of uncontrolled blood pressure
History of structural heart disease
History of epilepsy
History of closed angle glaucoma
History of diabetes mellitus
History of coronary artery disease
Ejection fraction < 50%
Use of monoamine oxidase inhibitors (MAOIs)
Use of selective serotonin reuptake inhibitors (SSRIs)
Use of anticonvulsants
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Age
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From 10 years old to 70 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
- Investigator
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Sample size
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Target sample size:
50
Actual sample size reached:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are randomized and divided into two groups based on permutation blocks and they fall into one of the medication and placebo 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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This is a double-blind study. Both patients and investigators were blinded to the medication and placebo.
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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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2018-07-25, 1397/05/03
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1397.273
Health conditions studied
1
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Description of health condition studied
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Syncope
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ICD-10 code
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R55
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ICD-10 code description
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Syncope and collapse
Primary outcomes
1
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Description
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The number of (pre-)syncopal episodes
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Timepoint
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Follow-up visit at month 1 and 3
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Method of measurement
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Based on history and physical exam
Secondary outcomes
1
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Description
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Anxiety
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Timepoint
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Follow-up visit on month 3
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Method of measurement
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Hospital Anxiety and Depression Scale Questionnaire
2
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Description
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Depression
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Timepoint
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Follow-up visit on month 3
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Method of measurement
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Hospital Anxiety and Depression Scale Questionnaire
3
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Description
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Physical quality of life
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Timepoint
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Follow-up visit on month 3
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Method of measurement
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36-Item Short Form Survey Questionnaire
4
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Description
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Mental quality of life
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Timepoint
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Follow-up visit on month 3
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Method of measurement
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36-Item Short Form Survey Questionnaire
Intervention groups
1
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Description
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Intervention group: Atomoxetine 20 mg daily, taken orally, for 2 weeks and 40 mg daily for another 2 weeks, if tolerated. The pills will be sealed in 2 envelopes for each 2-week period: 14 pills (20 mg) in envelope A and 14 pills (40 mg) in envelope B.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo pills are administered orally daily for a period of 4 weeks in envelopes A and B as discussed earlier. Placebos will be produced by the pharmacy department of Tehran University of Medical Sciences.
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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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Yes
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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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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data will be published
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When the data will become available and for how long
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2019
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To whom data/document is available
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All
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Under which criteria data/document could be used
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All
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From where data/document is obtainable
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Dr Masih Tajdini
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What processes are involved for a request to access data/document
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Appointment
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Comments
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