Condition 1: Generalized anxiety disorder. Condition 2: mitral valve prolapse. Generalized anxiety disorder Mitral (valve) prolapse
Conditions
Interventions
Intervention 1: Propranolol 10mg three times a day for eight weeks. Intervention 2: Propranolol 10mg three times a day and Fluoxetine 10mg once daily for eight weeks.
Treatment - Drugs
Propranolol 10mg three times a day for eight weeks
Propranolol 10mg three times a day and Fluoxetine 10mg once daily for eight weeks
Sponsors
Sabzevar University of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain severity. Timepoint: Every week. Method of measurement: Base on 11 point likert scale.;Echocardiographic changes. Timepoint: At the begining and the end of study. Method of measurement: By use of transthoracic echocardiography.;Palpitation. Timepoint: Every week. Method of measurement: Base on 11 point likert scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;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.;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.;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.;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.;Irregular drug use. Timepoint: Every two weeks. Method of measurement: Patients will be asked about using their medications.;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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMajid Jalalyazdi
Mashhad University of Medical Science
Outcome results
None listed