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IRCT20090117001556N155 IRCT 2023-12-03 Tehran University of Medical Sciences Minocycline for the treatment of the acute phase of mania Effect of Minocycline as adjuvant therapy for the acute phase of mania: A randomized, double-blind, placebo-controlled trial 2024-01-21 anticipated 50 Complete https://irct.ir/trial/74080 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 Bipolar disorder. Intervention 1: Control group: patients receive 900 mg of lithium, 4 mg of Risperidone, and placebo, daily for 6 weeks. Intervention 2: Intervention group: patients receive 900 mg of lithium, 4 mg of Risperidone, and 100 mg of Minocycline, daily 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 2023 to 2028 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) Diagnosis of bipolar disorder based on DSM-V criteria Age between 55-18 years The score of 20 (at least) based on Young Mania Rating Scale 18 years 55 years Both Systemic disease including hypothyroidism or hyperthyroidism Cardiac conduction disorder Drug dependence except nicotine and caffeine Presence of serious suicide risk IQ less than 70 History of allergy to any of the used drugs Pregnant and lactating women The use of drugs that cause symptoms similar to mania like psychostimulants F31 Bipolar disorder Placebo Treatment - Drugs Control group: patients receive 900 mg of lithium, 4 mg of Risperidone, and placebo, daily for 6 weeks. Intervention group: patients receive 900 mg of lithium, 4 mg of Risperidone, and 100 mg of Minocycline, daily for 6 weeks. The severity of manic phase symptoms. Timepoint: Weeks: 0 - 2 - 4 - 6. Method of measurement: By Young Mania Rating Scale (YMRS). Tehran University of Medical Sciences Approved 2023-11-01 Ethics Committee of School of Medicine, Tehran University of Medical Sciences Tehran University of Medical Sciences, Pour Sina St., Qods St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)