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IRCT20130812014333N158 IRCT 2020-12-30 Kermanshah University of Medical Sciences Study of the effect of melatium on prevention of relapse in patients with bipolar disorder Study of the effect of melatium on prevention of relapse in patients with bipolar disorder compared with placebo 2021-01-04 anticipated 104 Complete https://irct.ir/trial/53056 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random blocking. 26 blocks (10 blocks of 10 people, 8 blocks of 8 people, 6 blocks of 6 people, and two blocks of 2 people) will be determined and people will be randomly divided into two intervention and control groups , Blinding description: In this study, the experimenter and the subject do not know which study group (intervention or control) the patient is in. 3 Bipolar disorder. Intervention 1: The intervention group will receive 30 capsules of melatium (effective ingredients are 3 mg of melatonin and 600 mg of lithium per standardized capsule) every 24 hours for 12 weeks. Intervention 2: The control group will receive 30 placebo capsules (starch with 600 mg of lithium) every 24 hours for 12 weeks. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 6 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: Send E-mail to the responsible for the update to get the documentation How to obtain: Documentation will be emailed within a 25-day timeframe Comments:
public Dr. Habibollah Khazaei
Farabi Hospital, Dolatabad Blvd, Isar Square
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 8216 0700 hakhazaie@gmail.com Kermanshah University of Medical Sciences scientific Dr. Habibollah Khazaei
Farabi Hospital, Dolatabad Blvd, Isar Square
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 8216 0700 hakhazaie@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 60 years No history of chronic physical illness such as diabetes Cardiovascular diseases, respiratory diseases and thyroid diseases Satisfaction of patients to participate in the study At least middle School degree At least one year has passed since the initial diagnosis of the disease 18 years 60 years Both Sleep disorders Simultaneously receive other non-therapeutic treatments Chronic mental disorders, especially personality disorders based on a psychiatrist interview Addiction to drugs Severe side effects of the drug; Patients who need hospitalization F31 Bipolar disorder Treatment - Drugs Placebo The intervention group will receive 30 capsules of melatium (effective ingredients are 3 mg of melatonin and 600 mg of lithium per standardized capsule) every 24 hours for 12 weeks. The control group will receive 30 placebo capsules (starch with 600 mg of lithium) every 24 hours for 12 weeks. Sleep quality. Timepoint: Weeks 3, 6, 9 and after the intervention. Method of measurement: Based on sleep quality questionnaire. Kermanshah University of Medical Sciences Approved 2020-11-10 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)