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Study of therapeutic effects of Atomoxtein in reducing the symptoms of patients with recurrent vasovagal syncope

Study of the therapeutic effects of Atomoxetine in comparison with placebo on reducing the incidence of symptoms in patients with recurrent vasovagal syncope;

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180125038507N1
Enrollment
50
Registered
2018-08-03
Start date
2018-07-23
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope. Syncope and collapse

Interventions

Intervention 1: 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 perio

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The number of (pre-)syncopal episodes. Timepoint: Follow-up visit at month 1 and 3. Method of measurement: Based on history and physical exam.

Secondary

MeasureTime frame
Anxiety. Timepoint: Follow-up visit on month 3. Method of measurement: Hospital Anxiety and Depression Scale Questionnaire.;Depression. Timepoint: Follow-up visit on month 3. Method of measurement: Hospital Anxiety and Depression Scale Questionnaire.;Physical quality of life. Timepoint: Follow-up visit on month 3. Method of measurement: 36-Item Short Form Survey Questionnaire.;Mental quality of life. Timepoint: Follow-up visit on month 3. Method of measurement: 36-Item Short Form Survey Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasih Tajdini

Tehran University of Medical Sciences

drmasih84@yahoo.com+98 21 8802 9600

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026