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IRCT20230626058586N3 IRCT 2024-02-19 Shahid Beheshti University of Medical Sciences Investigating the effect of agomelatine and sertraline on anxiety and depression comparing the efficiency of agomelatine & sertraline in the depression & anxiety of patients suffering from psychogenic non-epileptic seizure (PNES) 2024-02-19 anticipated 34 Complete https://irct.ir/trial/75259 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The website www.Randomization.com was used for randomization (online randomization). For this purpose, a simple randomization model was used. The randomization unit was individual and on this website, after specifying the number of intervention groups, which were three groups, and the required number in each of these groups, the website provided us with a random table of repetitions that represented the patient number. To hide the random allocation, central randomization was used. In this method, a random sequence is placed in the possession of an individual or a specific center, and sampling is done in one or more centers at the same time. Based on the order in which the participants entered the study, the researcher contacted the relevant center and asked about the random assignment of the participants to a special group, Blinding description: This study was double-blind and the patients and evaluators were unaware of the type of treatment. Also, the study data analyst only had the codes of the treatment groups (1, 2) and they were not able to distinguish the treatment groups. 2 Condition 1: anxiety. Condition 2: depression. Intervention 1: Intervention group: Agomelatine (25-50mg). Intervention 2: Intervention group: Sertraline (50-200 mg). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Roya Vaziri Harami
Shahid Madani street
Tehran Iran (Islamic Republic of) 1995825466 +98 21 7343 0300 md.r.vaziriharami@gmail.com Shahid Beheshti University of Medical Sciences scientific Roya Vaziri Harami
Shahid Madani street
Tehran Iran (Islamic Republic of) 1995825466 +98 21 7343 0300 md.r.vaziriharami@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Confirmation of PNES diagnosis by neurologist and psychiatrist Not suffering from mental disability and pregnancy Age range between 18-65 years Patient satisfaction 18 years 65 years Both Patient's lack of consent to continue participating in the study Confirmation of neurological disorder or other major disorders in addition to anxiety and depression during study Not coming for a follow-up visit. F06.4 F32.8 Anxiety disorder due to known physiological condition Other depressive episodes Treatment - Drugs Treatment - Drugs Intervention group: Agomelatine (25-50mg) Intervention group: Sertraline (50-200 mg) Depression. Timepoint: before the intervention and one month, two months and three months after the intervention. Method of measurement: Hamilton questionnaire. Anxiety. Timepoint: before the intervention and one month, two months and three months after the intervention. Method of measurement: Hamilton questionnaire. Seizure attacks. Timepoint: before the intervention and one month, two months and three months after the intervention. Method of measurement: EEG. Shahid Beheshti University of Medical Sciences Approved 2022-11-01 Ethics Committee of Shahid Beheshti University of Medical Sciences Ethics Committee of Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Velenjak st., Tehran. Tehran Tehran Iran (Islamic Republic of)