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IRCT20200913048705N1 IRCT 2022-02-22 Zahedan University of Medical Sciences The effect of melatonin on circadian rest-activity rhythms The effect of melatonin on circadian rest-activity rhythms during benzodiazepine tapering in patients with bipolar disorder and comparing it with the control group 2021-02-19 anticipated 66 Complete https://irct.ir/trial/53634 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The pockets containing medications (melatonin and placebo) were coded, and each code was written on the specific card. Thereafter, eligible patient was assigned to each group, randomly by selecting among shuffling cards. So, allocation sequence was concealed until the moment of assignment, and nobody knows what is the next treatment allocation must be. It should be mentioned that participants, health care providers, assessor and data collector unaware of the assigned intervention (allocated codes), Blinding description: Only participants in this study are blind to whether the drug is melatonin or placebo. 3 Bipolar disorder. Intervention 1: Intervention group: Patients with bipolar disorder which take melatonin when their usual benzodiazepine dosage was gradually tapered. Intervention 2: Control group: Patients with bipolar disorder which take placebo when their usual benzodiazepine dosage was gradually tapered. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Elham hajipour
Bahran hospital- Emam khomeini Ave- Zahedan- Iran
Zahedan Iran (Islamic Republic of) 9813913777 +98 54 3351 3777 psishahablotfinia@gmail.com Zahedan University of Medical Sciences scientific Dr. Mohsen Khosavi
Baharan hospital- Emam khomeini Ave- Zahedan- Iran
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3351 3777 dr_khosravi2016@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) 18 years or above Had a diagnosis of bipolar mood disorder based on DSM-5 Were treated with at least one antipsychotic drug and had a daily use of at least one benzodiazepine drug for a minimum of 3 months 18 years no limit Both Present with current violent or aggressive behavior Diagnosed with mental retardation, pervasive developmental disorder, dementia, Physical diseases including hepatic impairment, terminal illness, severe somatic comorbidity, or epilepsy Allergic to any compounds in the study medication Fertile women Breastfeeding women Lack of informed consent Comorbid mental disorders Use of opioids and other drugs F31 Bipolar disorder Treatment - Drugs Placebo Intervention group: Patients with bipolar disorder which take melatonin when their usual benzodiazepine dosage was gradually tapered Control group: Patients with bipolar disorder which take placebo when their usual benzodiazepine dosage was gradually tapered Circadian rest-activity rhythms. Timepoint: In days one, two and three. Method of measurement: Actigraph. Zahedan University of Medical Sciences Approved 2020-12-13 Ethics committee of Zahedan University of Medical Science Baharan hospital- Emam Khomeini Ave- Zahedan- Sistan and Baluchestan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)