]>
IRCT20090117001556N139 IRCT 2021-11-11 Tehran University of Medical Sciences Naproxen as an adjuvant therapy for the treatment of obsessive-compulsive disorder (OCD) Naproxen as an adjuvant therapy for the treatment of obsessive-compulsive disorder (OCD): A randomized double blind and placebo controlled clinical trial 2021-12-22 anticipated 50 Complete https://irct.ir/trial/59895 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups), Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Obsessive-compulsive disorder. Intervention 1: Intervention group: Patients are initially treated with fluoxetine 20 mg daily, reaching 80 mg per day by the end of the tenth week, plus naproxen 250 mg twice daily. Intervention 2: Control group: Patients are initially treated with fluoxetine 20 mg daily, reaching 80 mg daily by the end of the tenth week, plus placebo, twice daily. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2022 to 2027 To whom: academic researchers Conditions: users should cite the resource of data Where to obtain: Prof Shahin Akhondzadeh How to obtain: by E mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 60 years old Diagnosis of OCD based on DSM-5 Score of >21 in Yale–Brown obsessive-compulsive scale (Y-BOCS) 18 years 60 years Both Receiving any treatment up to 6 weeks before the start of the trial Diagnosis of another psychiatric disorder F42 Obsessive-compulsive disorder Treatment - Drugs Placebo Intervention group: Patients are initially treated with fluoxetine 20 mg daily, reaching 80 mg per day by the end of the tenth week, plus naproxen 250 mg twice daily. Control group: Patients are initially treated with fluoxetine 20 mg daily, reaching 80 mg daily by the end of the tenth week, plus placebo, twice daily. Severity of OCD symptoms. Timepoint: Baseline and weeks 5 and 10. Method of measurement: By Yale–Brown obsessive-compulsive scale (Y-BOCS). Tehran University of Medical Sciences Approved 2021-08-22 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)