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IRCT20181204041847N2 IRCT 2023-08-16 Shiraz University of Medical Sciences A comparative study on the effect of loading dose of lithium carbonate+ Quetiapine and standard dose of lithium carbonate+ Quetiapine on acute mania A comparative study on the effect of loading dose of lithium carbonate+ Quetiapine and standard dose of lithium carbonate+ Quetiapine on acute mania 2023-05-15 anticipated 60 Complete https://irct.ir/trial/68388 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method in this study will be the permutation block randomization method, such that "A" represents the subject receiving the intervention, and "B" represents the subject who receives the placebo. This method is based on 15 blocks in 4 permutations, taking into account all possible quadruple permutations (AABB, ABAB, ABBA, BAAB, BBAA and BABA) and assigning zero to nine (according to a random number table) to each of these permutations, Runs. (AABB Code 0, BABA Code 1, AABB Code 2, BBAA Code 3, BAAB Code 4, and ABBA Code 5 to 9) Then, using a random number table, 15 randomly selected (rows or columns) are selected, and the assigned permutation is written to each number. (The order of placing permutations next to each other is left to right respectively) and how all 60 people will be assigned to two groups A and B, Blinding description: participants are divided to two groups(treatment and control) and no one is aware of the treatment they are given but their clinical caregivers. to keep the cases blinded, during obtaining informed consent, it is explained to the patient that by entering this study, they may be placed in any of the control or treatment groups. After obtaining informed consent, the researcher conducts interviews and related follow-ups and does not know which group each patient belongs to. The caregiver, who is the head nurse of the ward in this research, records the patients' information about which group each patient belongs to and keeps it with them until the time of data analysis. 3 Bipolar 1 disorder (acute manic phase). Intervention 1: Intervention group: receive loading dose of lithium carbonate (20 mg/kg) in form of a stat dose. Intervention 2: Control group: this group receives routine dose of Lithium carbonate (300 mg TiD). Yes - There is a plan to make this available What will be shared: Patients' data will be published as ymrs scores. only the patr including major data When: 6 months after publication To whom: only for ethics comitee Conditions: for further researches Where to obtain: psychiatry department, Shiraz university of medical sciences How to obtain: written letter of the ethics comittee Comments:
public Ebrahim Moghimi Sarani
Hafez street, Ibne sina hospital
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3228 9601 moghimiebrahim@yahoo.com Shiraz University of Medical Sciences scientific Ebrahim Moghimi Sarani
Hafez street, Ibne sina hospital
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3228 9601 moghimiebrahim@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) known cases of Bipolar type 1 disorder (B1D) Acute manic phase No consumption of lithium carbonate since at least ten days ago. 18 years 65 years Both patients with each kind of cardiac conditions or any positive past history of cardiac diseases- any abnormal findings in their first ecg during this admission(arrhythmia, ST change,...) positive history of psoriasis hypothyroidism or hyperthyroidism cases of chronic kidney disease or acute kidney injury any allergy or history of anaphylaxis with lithium carbonate F31.2 Bipolar disorder, current episode manic severe with psychotic features Treatment - Drugs Treatment - Drugs Intervention group: receive loading dose of lithium carbonate (20 mg/kg) in form of a stat dose. Control group: this group receives routine dose of Lithium carbonate (300 mg TiD) Grades on basis of Young mania rating scale (YMRS). Timepoint: days: 0- 3-7-14. Method of measurement: (YMRS)Young mania rating scale. Ecg change. Timepoint: pre medication (day 0), day 3, day 7, day 14. Method of measurement: any ecg change in comparison with baseline. Renal function. Timepoint: day 0,5,10. Method of measurement: serum bun, cr. Serum lithium level. Timepoint: day 0,7,14. Method of measurement: serum lithium lab test. Shiraz University of Medical Sciences Approved 2023-02-07 Ethics committee of Shiraz University of Medical Sciences Karim Khan Zand Blvd Shiraz Fars Iran (Islamic Republic of)