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IRCT20251011067589N1 IRCT 2025-11-09 Ahvaz University of Medical Sciences Investigating the Effect of Adding N-acetylcysteine to Treatment in Bipolar Depression Investigating the effect of adding N-acetylcysteine to treatment compared to placebo on improving depressive symptoms in patients with bipolar disorder: a clinical trial 2025-12-22 anticipated 50 Complete https://irct.ir/trial/86911 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning the intervention to individuals is randomly divided into two groups of intervention and control by the method of random permutation blocks with a size of 4 random blocks (using the table related to random permutations). The randomization list is prepared by a statistician. In this method, group A is related to the intervention and group B is considered as the control and is classified into 4 blocks including AABB, ABAB, ABBA, BBAA, BABA, BAAB.T o hide the assignment of individuals in the intervention and control groups, 20 even four-digit numbers will be selected as the codes of the participants in the control group and 20 four-digit individuals as the codes of the participants in the intervention group will be selected from a random number table. Then, the numbers of intervention and control groups are placed in sealed envelopes, respectively, and are randomly delivered by one of the personnel to the eligible individuals participating in the study. Random allocation software is also used for randomization. The site https://www.randomizer.org/ is used for randomization. In the empty fields, the total number of random numbers and the number of random numbers in each group, the range of numbers are entered and the output is received as an excel, Blinding description: In this study, both the investigator and the patient are unaware of which participants in each group are receiving the drug or the placebo. The drug and the placebo will be identical in appearance, color, smell, and taste. 2-3 Depression in Bipolar patients. Intervention 1: Intervention Group: Patients in the intervention group will receive, in addition to the standard pharmacological treatment they have been already receiving, a daily dose of 1800 mg to 2000 mg of N-acetylcysteine tablets for a duration of 8 weeks. Intervention 2: Control group: Patients in the control group will receive, in addition to the standard pharmacological treatment they have been already receiving, a placebo identical to the N-acetylcysteine tablet (in shape, smell, taste, size, and color) for a duration of 8 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 A decision will be made after the study has been completed.
public Shahin Norouzi
Golestan Hospital of Ahvaz, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 4693955599 +98 61 3320 4501 norouzi-s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Shahin Norouzi
Golestan Hospital of Ahvaz, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 4693955599 +98 61 3320 4501 norouzi-s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with bipolar depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. A score greater than 8 on the Hamilton Depression Rating Scale. Patients hospitalized in the Psychiatry Ward of Golestan Hospital Patients in the age range of 18-65 years 18 years 65 years Both The use of any other medication that has antidepressant effects, except for the study drug, or mood stabilizers or antipsychotics that have been initiated for the patient. The presence of comorbid psychiatric disorders such as schizoaffective disorder or other psychotic disorders like schizophrenia Acute substance, sedative, or alcohol dependence or abuse within the past 12 months (excluding nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for substance dependence, or a positive urine drug test at the start of the study Sensitivity to N-acetylcysteine or to any of the components present in the placebo. Diagnosis of major depressive disorder (unipolar depression) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Diagnosis of a manic episode based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Individuals with intellectual disabilities or other cognitive disorders Neurological disorders such as dementia, delirium, head trauma, or seizure disorders Pregnant women F31.4 Bipolar disorder, current episode depressed, severe, without psychotic features Treatment - Drugs Treatment - Drugs Intervention Group: Patients in the intervention group will receive, in addition to the standard pharmacological treatment they have been already receiving, a daily dose of 1800 mg to 2000 mg of N-acetylcysteine tablets for a duration of 8 weeks. Control group: Patients in the control group will receive, in addition to the standard pharmacological treatment they have been already receiving, a placebo identical to the N-acetylcysteine tablet (in shape, smell, taste, size, and color) for a duration of 8 weeks. Depressive symptoms. Timepoint: At the beginning of study and 4th and 8th week of study. Method of measurement: Hamilton Depression Rating Scale. Cognitive function. Timepoint: At the beginning of study and 4th and 8th week of study. Method of measurement: Montreal Cognitive Assessment. Ahvaz University of Medical Sciences Approved 2025-09-17 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Ahvaz, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)