Assessing the effect of fluoxetine on the clinical symptoms and echocardiographic findings in patients with mitral valve prolapse and generalized anxiety disorder, referred to Mashhad outpatient cardiology clinics in 2015.
Evaluation of fluoxetine effect on clinical symptoms and echocardiographic findings in patients with mitral valve prolapse and generalized anxiety disorder is the aim of this study. Patients who their mitral valve prolapse is confirmed by echocardiography and have clinical symptoms of generalized anxiety disorder will fill a validated Persian version of GAD-7 questionnaire and enter the study. Medical illnesses which directly or indirectly can induce anxiety or patients who are taking any drugs which can affect generalized anxiety disorder will be excluding. According to the study sample size which is calculated as 60 participants, patients will be randomly categorized in to two groups. Each group will take their medication for 8 weeks. First group will take 10mg of propranolol three times a day and the second group will take same dose of propranolol plus 10mg fluoxetine daily. Each two weeks, the patients will be evaluated for exclusion criteria by physicians and each week patients will document their symptoms according to the 11 question likert scale. After 8 weeks of study period, each patient will undergo echocardiography and the results will be documented in their questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102819721N1
Registration date:2015-01-31, 1393/11/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-31, 1393/11/11
Registrant information
Name
Reza Jafarzadeh Esfehani
Name of organization / entity
Sabzevar University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 3015
Email address
jafarzadehr911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Science
Expected recruitment start date
2015-03-17, 1393/12/26
Expected recruitment end date
2015-07-20, 1394/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of fluoxetine on the clinical symptoms and echocardiographic findings in patients with mitral valve prolapse and generalized anxiety disorder, referred to Mashhad outpatient cardiology clinics in 2015.
Public title
Effect of fluoxetine on clinical symptoms and echocardiographic findings in patients with mitral valve prolapse and generalized anxiety disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who their mitral valve prolapse (MVP) is confirmed by echocardiography and have clinical symptoms of MVP (at least must have palpitation or chest pain).Exclusion criteria: medical conditions which directly or indirectly can induce anxiety including anemia;hypercalemia;hypoglycemia;drugs or alcohol withdrawal syndrome;vertigo;thyrotoxicosis;hypercapnea;hyponatremia;central nervous system disorders such as seizures;asthma;ischemic heart disease;malignancies;drugs such as anticonvulsants;antimicrobials;broncho dilators;digitalis;estrogen;insulin;nonsteroidal anti-inflammatory drugs;antidepressants;antihistamines;calcium channel blockers;dopamine;inotropics;levodopa;thyroxine;corticosteroids;smoking;patients who dont full fill DSM-IV criteria and are not included in generalized anxiety disorder category;any other documented psychological problems;patients who are not interested in continuing medications and are willing to be excluded;patients who do not take their medications regularly;patients who are prescribed with other drugs during the study;patients who are not capable to continue study because of drug adverse effects or need to change their drugs according to physicians order.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of medical science research and technology department
Street address
Medicine Faculty - building No.2 - 5th kilometer of Tehran road - Sabzevar - Iran
City
Sabzevar
Postal code
Approval date
2014-08-04, 1393/05/13
Ethics committee reference number
3/33/ک پ ژ
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
mitral valve prolapse
ICD-10 code
I34.1
ICD-10 code description
Mitral (valve) prolapse
Primary outcomes
1
Description
Pain severity
Timepoint
Every week
Method of measurement
Base on 11 point likert scale
2
Description
Echocardiographic changes
Timepoint
At the begining and the end of study
Method of measurement
By use of transthoracic echocardiography
3
Description
Palpitation
Timepoint
Every week
Method of measurement
Base on 11 point likert scale
Secondary outcomes
1
Description
Drugs adverse effects
Timepoint
Any point in the study period
Method of measurement
Physician will ask participants about drug adverse reactions in each visit and also the participants will be educated to report any cardio-respiratory or mood changes during the study.
2
Description
Onset of new disease
Timepoint
Any point in the study period
Method of measurement
Participants will call the physician any time they get new illnesses which is mentioned in exclusion criteria of the study
3
Description
Start using new drugs
Timepoint
Any point in the study period
Method of measurement
Participants will call their physician any time they start new drugs
4
Description
Generalized anxiety disorder become worsen
Timepoint
Every two weeks or any time in the study
Method of measurement
Every participants mood will be evaluated in each visit and also the participants will call their physician any time they fill their mood is becoming worsen
5
Description
Worsening of cardiac condition
Timepoint
Every two week or any time in the study
Method of measurement
In each visit the physician will evaluate the participants cardiac condition and the patients will be educated to immediately report any changes in their conditions or any alarm signs
6
Description
Irregular drug use
Timepoint
Every two weeks
Method of measurement
Patients will be asked about using their medications
7
Description
Failure in continuing the study
Timepoint
Any point in the study period
Method of measurement
Personal willing to change their drugs or exiting the study because of taking long trips or personal willing
Intervention groups
1
Description
Propranolol 10mg three times a day for eight weeks
Category
Treatment - Drugs
2
Description
Propranolol 10mg three times a day and Fluoxetine 10mg once daily for eight weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Educational, Research and Treatment Center Clinics
Full name of responsible person
Majid Jalalyazdi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Mohammad Mohammad-Zadeh (Vice Chancellor for Research(
Street address
Department of research and technology - Sabzevar University of Medical Science - building No.1 - 5th kilometer of Tehran road - Sabzevar - Iran
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?