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IRCT20090117001556N125 IRCT 2020-05-17 Tehran University of Medical Sciences The effects of Celecoxib in the treatment of postpartum depression with mild intensity to the average Studying the effects of Celecoxib as monotherapy in the treatment of postpartum depression with mild intensity to the average: response to treatment of Celecoxib by area Brain-Derived Neurotrophic Factor (BDNF) and inflammatory cytokines (TNFα, IFNγ , IL-1Α, IL-1Β IL-6, IL-8) 2020-06-21 anticipated 50 Complete https://irct.ir/trial/48148 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 Postpartum depression. Intervention 1: Intervention group: Celecoxib capsule (Daroopakhsh, Tehran), 200 mg BID, oral (p.o.), for 8 weeks. Intervention 2: Control group: Placebo (BID), oral (p.o.), for 8 weeks. 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 2021 to 2026 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 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 Prof. 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 45 Having mild to moderate depression according to Hamilton Depression Rating Scale (HAM-D) 18 years 45 years Female Having severe depression according to Hamilton Depression Rating Scale (HAM-D or HDRS) Addiction to drugs Addiction to alcohol Presence of Thyroid disease Receiving any antidepressant medications during past one month prior to the trial Receiving Electroconvulsive therapy during past two months prior to the trial Any other diagnosis according to axis-1, DSM-5 Having a risk of suicide based on doctor's clinical judgement or having a score of >2 in suicide item of Hamilton Depression Rating Scale (HAM-D or HDRS) Concomitant use of medications that increase the risk of gastrointestinal bleeding Presence of cardiovascular disease Pregnant and lactating women Risk of child murder O90.6 Postpartum mood disturbance Treatment - Drugs Placebo Intervention group: Celecoxib capsule (Daroopakhsh, Tehran), 200 mg BID, oral (p.o.), for 8 weeks Control group: Placebo (BID), oral (p.o.), for 8 weeks Severity of depression. Timepoint: Baseline and weeks 2, 4, 6, and 8. Method of measurement: By Hamilton Depression Rating Scale (HAM-D or HDRS). Tehran University of Medical Sciences Approved 2020-03-17 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)