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IRCT20090117001556N116 IRCT 2019-03-14 Tehran University of Medical Sciences Pentoxifylline as adjuvant therapy in the treatment of major depression Pentoxifylline as adjuvant therapy in the treatment of major depression: a randomised and double blind study 2019-04-13 anticipated 50 Complete https://irct.ir/trial/38279 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: tablet sertralin 100 mg/day plus Capsule pentoxyfylline 400 mg TDS as intervention group for 6 weeks. Intervention 2: Control group: tablet sertralin 100 mg/day plus Capsule placebo as control group for 6 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: by citing the resourse Where to obtain: Professor Shahin Akhondzadeh How to obtain: by E mail Comments:
public Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street,
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 18 years 50 years Both Presence of psychosis Any other mental disorder Hypothyroidism Cardiovascular disease Pregnancy or nursing women Renal failure Allergy to Theophylline, Aminophylline, and pentoxyfylline Hepatic failure Peptic ulcer Receiving antiplatelets agents or anticoagulants Receiving NSAIDs F32.1 Major depressive disorder, single episode, moderate Treatment - Drugs Placebo Intervention group: tablet sertralin 100 mg/day plus Capsule pentoxyfylline 400 mg TDS as intervention group for 6 weeks Control group: tablet sertralin 100 mg/day plus Capsule placebo as control group 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 2019-03-11 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)