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IRCT20090117001556N121 IRCT 2019-10-19 Tehran University of Medical Sciences Adalimumab as a adjuvant therapy in modrate to sever MDD Adalimumab as a adjuvant therapy in modrate to sever MDD in patients with CRP greater than or equal to 3mgr/lit : a double blind and randomized Trial 2019-11-21 anticipated 50 Complete https://irct.ir/trial/43096 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random permuted block, Blinding description: The participants, clinicians and outcome raters will be blind regarding grouping. 3 Major Depressive Disorder. Intervention 1: Intervention group: Adalimumab(iv) 5 mg/kg at the beginning plus tablet sertralin up to100 mg/day for 6 weeks. Intervention 2: Control group: placebo(iv) at the begenning plus tablet sertralin up to100 mg/day for 6 weeks. Yes - There is a plan to make this available What will be shared: All data will be distributed through final report When: from 2021 to 2026 To whom: academic researchers Conditions: by email Where to obtain: Prof Shahin Akhondzadeh How to obtain: s.akhond@sina.tums.ac.ir 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 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) Presence of Major Depressive Disorder based on DSM-5 criteria Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 19 CRP equals or more than 3mg/lit 18 years 60 years Both Psychotic symptoms Any other mental disorder Hypothyroidism Cardiovascular disease Pregnant or nursing women History of tuberculosis Autoimmune disease Viral hepatitis Chronic or recurrent infections Receiving ECT during the last two months Significant suicidal ideation Substance use HIV F32.1 Major depressive disorder, single episode, moderate Treatment - Drugs Placebo Intervention group: Adalimumab(iv) 5 mg/kg at the beginning plus tablet sertralin up to100 mg/day for 6 weeks Control group: placebo(iv) at the begenning plus tablet sertralin up to100 mg/day for 6 weeks Severity of depression. Timepoint: Baseline and weeks 2,4 and 6. Method of measurement: By Hamiltion Depression Rating Scale 17-Item. Tehran University of Medical Sciences Approved 2019-10-03 Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blv Tehran Tehran Iran (Islamic Republic of)