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IRCT20190316043072N2 IRCT 2021-04-29 Karaj University of Medical Sciences The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania(sleep , appetite) of type 1 bipolar disorder in randomized, double-blind, placebo-controlled clinical trial 2021-04-21 anticipated 60 Complete https://irct.ir/trial/55413 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method used in this study will be the block randomization method developed by the statistics expert by using the STATA software in a randomization list format. Then, according to the randomization list, the type of intervention for each individual will be written on paper, and the paper will be put in a sealed envelope. Envelopes will be numbered according to the randomization list. The physician will examine the patient's eligibility, and if the patient is eligible, she will tell the hospital research assistant. The research assistant will then provide the sealed envelope to the physician, and the physician will begin the intervention according to the contents of the envelope, Blinding description: Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Due to the type of intervention, participants are aware of the type of treatment. 3 Bipolar disorder. Intervention 1: Intervention group: Taking valproate Sodium tablet (200 mg), 3 times daily with spironolactone tablet (50 mg) , Daily for 8 weeks. Intervention 2: Control group: Taking valproate Sodium tablet (200 mg), 3 times daily with placebo in tablet form, Daily for 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 It is not yet known if there will be a plan to make this available
public Dr. Atefe Zandifar
Alborz University of Medical Sciences, North Taleghani Blvd., Taleghani Square, Karaj
Karaj Iran (Islamic Republic of) 3149779453 +98 32563328026 zandifaratefe@gmail.com Karaj University of Medical Sciences scientific Dr. Atefe Zandifar
Alborz University of Medical Sciences, North Taleghani Blvd., Taleghani Square, Karaj
Karaj Iran (Islamic Republic of) 3149779453 +98 32563328026 zandifaratefe@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Having DSM-V diagnostic criteria for patients with bipolar disorder with mania phase Age 18 to 50 years Their minimum score is 14 based on Young Mania Rating Scale (YMRS) 18 years 55 years Both Neurological disease Cardiovascular and hepatic disease IQ less than 70 Drug abuse (except nicotine and caffeine) pregnancy Taking drugs that interfere with spironolactone . F31 Bipolar disorder Treatment - Drugs Placebo Intervention group: Taking valproate Sodium tablet (200 mg), 3 times daily with spironolactone tablet (50 mg) , Daily for 8 weeks Control group: Taking valproate Sodium tablet (200 mg), 3 times daily with placebo in tablet form, Daily for 8 weeks Mood symptoms. Timepoint: Before and after the intervention. Method of measurement: Young Mania Rating Scale (YMRS), Mini-Mental State Examination (MMSE). Sleep quality improvement. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Appetite quality improvement. Timepoint: Before and after the intervention. Method of measurement: Simple appetite questionnaire. Karaj University of Medical Sciences Approved 2021-03-06 Ethics committee of Alborz University of Medical Sciences Ethics committee unit, Vice Chancellor for Research, No.20, Saffarian alley, 45 Metri Golshahr street karaj Alborz Iran (Islamic Republic of)