]>
IRCT201112188106N1 IRCT 2012-01-14 Mashhad University of Medical Sciences The assessment of folic Acid and vitamin B6 effects in bipolar patients The assessment of folic Acid and vitamin B6 effects add-in sodium valproate in bipolar mood Disorder in Acute phase of mania 2011-04-04 anticipated 43 Complete https://irct.ir/trial/8525 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Bipolar disorder. Intervention 1: Case group 1: folic acid,oral tab 5mg,once a day,for six weeks. Intervention 2: Case group 2:vitamin B6,oral tab 40mg,towice a day, for six weeks. Intervention 3: Control group:placebo,oral tab,once a day,for six weeks.
public Alireza Ebrahimi
Ebne Sina Psychiatric Hospital,before Bou Ali square,Horre Ameli Bolvard,Mashhad
Mashhad Iran (Islamic Republic of) +98 51 1883 1993 ebrahimia871@mums.ac.ir/alireza.ebrahimi37@yahoo.com Mashhad University of Medical Sciences scientific Dr. Ali Talaei
Ebne Sina Psychiatric Hospital,before Bou Ali Square,Horre Ameli Bolvard,Mashhad
Mashhad Iran (Islamic Republic of) +98 51 1761 4021 TalaeiA@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:1)Patients age between 18 to 45 years old according to birth certificate.2)Diagnosis of bipolar mood disorder I with recent episode of mania according to DSM IV TR diagnosis criteria.3)Roling out diagnosis of schizophrenia,delirium,anorexia nervosa,bulimia,autism,substance abuse(at least during 3 months ago ),mental retardation,adhd.4)Absence of psychiatric hospitalization history during 3 months ago.5)Absence of seizure history6)Absence of severe allergy history.7)Filling out informed consent.8)Absence of allergic history to sodium valproate. Exclusion criteria:1)Patients who evaluate at risk of suicide or homicide according to psychiatric diagnosis.2)Female patients are doubted for pregnancy, should test serum pregnancy test and will exclude from study if it is positive.3)Patients who take other drugs such as antimanic drugs that could not be able to stop them in two weeks before study or during it. 18 years 45 years Both F31.9 Bipolar affective disorder, unspecified Treatment - Drugs Treatment - Drugs Placebo Case group 1: folic acid,oral tab 5mg,once a day,for six weeks Case group 2:vitamin B6,oral tab 40mg,towice a day, for six weeks Control group:placebo,oral tab,once a day,for six weeks Severity of mania. Timepoint: Baseline,End of the third week,End of the six week. Method of measurement: Jung Mania Rating Scale(YMRS). Cognitive scale. Timepoint: Baseline,End of the third week,End of the six week. Method of measurement: Mini Mental State Examination (MMSE). Mashhad University of Medical Sciences Approved 2011-03-12 Mashhad University of Medical Sciences University Research Affairs-Research Vice-Mashhad University of Medical Science.Mashhad Mashhad Iran (Islamic Republic of)