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IRCT20190316043072N4 IRCT 2024-01-05 Karaj University of Medical Sciences Investigating of vitamin B6 in Bipolar Mood disorder Investigating the effect of vitamin B6 as an add-on treatment to lithium compared to placebo on the symptoms of acute mania and the recurrence of mood episodes and suicidal thoughts in patients with bipolar disorder type 1; A double-blind clinical trial 2024-01-21 anticipated 80 Complete https://irct.ir/trial/73741 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method used in this study will be the block method, which will be designed by a statistician and STATA software, mainly a randomization list. Then, according to the randomization list, the type of intervention desired for each person will be written on a paper and the paper will be placed in a sealed envelope. The envelopes will be numbered according to the order included in the list. The doctor checks the conditions of the patient to enter the study and if he is eligible, he informs the resident research expert at the hospital. Then the research expert will provide the sealed envelope to the doctor and the doctor will start the desired intervention according to the content inside the envelope, Blinding description: Patients do not know the type of treatment. Prescribed medicines are in the form of pills with the same shape ,color, size, smell and taste. Completing the final information is the responsibility of the person who is unaware of the type of treatment. Also, the statistician will be a blind treatment type. 3 Bipolar disorder. Intervention 1: Intervention group: lithium carbonate tablets (300 mg), three times a day along with vitamin B6 (40 mg) a day for 24 weeks. Intervention 2: Control group: lithium carbonate tablets (300 mg), three times a day with a placebo for 24 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 Its release schedule is not yet known
public Dr. Atefeh Zandifar
Karaj; Taleghani Square; North Taleghani Boulevard; Alborz University of Medical Sciences
Karaj Iran (Islamic Republic of) 3149779453 0098 32563328026 zandifaratefe@gmail.com Karaj University of Medical Sciences scientific Dr. Atefeh Zandifar
Karaj; Taleghani Square; North Taleghani Boulevard; Alborz University of Medical Sciences
Karaj Iran (Islamic Republic of) 3149779453 0098 32563328026 zandifaratefe@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Having DSM-V diagnostic criteria for bipolar patients (through a semi-structured interview by a psychiatrist and confirming the diagnosis with a score of at least 20 on the Young Mania scale). Being at the age of 18 to 65 years old 18 years 65 years Both Suffering from neurological disease, cardiovascular and liver disease and chronic kidney disease IQ less than 70 Drug abuse (except nicotine and caffeine) History of drug sensitivity to lithium carbonate or vitamin B6 Pregnancy and breastfeeding chronic kidney disease (CKD) F31 Bipolar disorder Treatment - Drugs Placebo Intervention group: lithium carbonate tablets (300 mg), three times a day along with vitamin B6 (40 mg) a day for 24 weeks. Control group: lithium carbonate tablets (300 mg), three times a day with a placebo for 24 weeks Mood symptoms. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Young Mania standard questionnaire and brief clinical examination test. Improve sleep quality. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Petersburg Sleep Quality Questionnaire. Cognitive symptoms. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Mini-Mental State Examination (MMSE). Suicidal thoughts. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Beck suicide questionnaire. Symptoms of depression. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Beck depression questionnaire. Anxiety symptoms. Timepoint: Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32). Method of measurement: Beck's anxiety questionnaire. Karaj University of Medical Sciences Approved 2023-12-18 Ethics Committee of Alborz University of Medical Sciences Ethics committee unit, Research and Technology Deputy, No. 20, Safarian Alley, Golshahr 45 Meter street Karaj Alborz Iran (Islamic Republic of)