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IRCT20151022024650N2 IRCT 2023-01-01 Tabriz University of Medical Sciences The effect of bupropion on the improvement of sexual side effects caused by SSRI use Investigating the effect of bupropion on the sexual function of patients with sexual side effects caused by SSRI use, a double-blind clinical trial 2023-01-21 anticipated 60 Complete https://irct.ir/trial/65101 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: block randomization; Random unit: individual. َRandomization tool: An online randomization website. Sequence building: using block randomization method with block size of 4. Concealing method: using closed and opaque envelopes, Blinding description: In this study, clinical evaluator and analyzer are blinded. The allocation of patients into two groups A and B is done by a qualified nurse who has no aware of the actions performed in the two groups. Clinical examination and outcome evaluation will be record by a qualified nurse without any information about the type of intervention. 2-3 Sexual dysfunction. Intervention 1: Intervention group: after justifying the patients and providing the necessary training, 75 mg bupropion tablets are prescribed once a day during the study (8 weeks). Intervention 2: Control group: after justifying the patients and providing the necessary training, only the prescribed treatment similar to the intervention group and without the use of bupropion is prescribed during the study (8 weeks). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After completing the research and summarizing the results, it will be decided.
public Dr. Elham Ghasemi
29 Bahman street., Tabriz., Iran.
Tabriz Iran (Islamic Republic of) ۳۶۱۵۶۷۳۳۲۷ +98 939 667 6405 dr.egh92@gmail.com Tabriz University of Medical Sciences scientific Dr. Sepideh Harizchi Ghadim
29 Bahman street., Tabriz., Iran
Tabriz Iran (Islamic Republic of) ۳۶۱۵۶۷۳۳۲۷ +98 939 667 6405 herizchis@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients under SSRI treatment for at least three consecutive months; having sexual dysfunction for at least the last two months; married and sexually active; Age range 15-55 years; stable vital signs. 15 years 55 years Female The presence of digestive problems such as severe nausea and vomiting and SSRI intolerance; The presence of concurrent chronic liver or kidney disease; The presence of any anatomical problem of the reproductive system; The existence of any severe or relatively severe hormonal disorder; Absence of pregnancy; Lack of breastfeeding; Non-participation in the study. F52 Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Treatment - Drugs Intervention group: after justifying the patients and providing the necessary training, 75 mg bupropion tablets are prescribed once a day during the study (8 weeks). Control group: after justifying the patients and providing the necessary training, only the prescribed treatment similar to the intervention group and without the use of bupropion is prescribed during the study (8 weeks). Measuring sexual satisfaction. Timepoint: Once a Month. Method of measurement: Hudson's Standardized Sexual Satisfaction Questionnaire (ISS). Measuring sexual performance. Timepoint: Once a Month. Method of measurement: Rozen Standardized Women's Sexual Performance Questionnaire (FSFI). Tabriz University of Medical Sciences Approved 2022-06-15 Ethics committee of Tabriz University of Medical Sciences 29 Bahman street., Tabriz., Iran Tabriz East Azarbaijan Iran (Islamic Republic of)