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IRCT20251208068253N4 IRCT 2026-07-01 Mashhad University of Medical Sciences Evaluation of the Efficacy of Lacosamide in Mania Comparison of the Efficacy of Lacosamide versus Valproate in the Treatment of Acute Mania in Bipolar Disorder 2026-07-23 anticipated 80 Recruiting https://irct.ir/trial/91114 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is designed using balanced blocks with block sizes of 4 and 6. A total of 8 blocks of size 4 and 8 blocks of size 6 are planned for patient allocation. Randomization will be performed using a block design with variable block sizes to assign participants to the intervention and control groups. To ensure allocation concealment, the randomization process will be conducted using Random Allocation Software, version 2.0. Accordingly, after obtaining informed consent and confirming eligibility criteria, the researcher will enter the patient's initial identification data into the software, and the treatment group will be assigned instantly and automatically. This method eliminates any possibility of predicting group assignment and provides the highest level of blinding for the study, Blinding description: This study is designed as a double-blind trial, meaning that both the participants and the study personnel responsible for drug allocation will be unaware of the treatment assignments. To maintain blinding, the study medications will be prepared and dispensed to patients by nurses independent of the study team, using identical, coded packaging (designated as A/B). 3 Bipolar mood disorder. Intervention 1: Control group: Treatment with valproate is initiated at a dose of 200 mg three times daily and titrated over 2 weeks to reach a target dose of 20 mg/kg/day. Patients will be assessed at baseline (admission), and on Day 3, Week 1, and Week 2 using the YMRS and CGI, administered by a resident physician through patient interview. In addition, all patients will receive standard-of-care treatment with risperidone. Intervention 2: Intervention group: Treatment is initiated at a starting dose of 50 mg/day and gradually titrated up to 200–300 mg/day. Patients will be assessed at baseline (admission), and on Day 3, Week 1, and Week 2 using the YMRS and CGI scales, administered by a resident physician through patient interview. In addition, all patients will receive standard-of-care treatment with risperidone. Yes - There is a plan to make this available What will be shared: A de-identified individual participant dataset including demographic information, cognitive performance scores, behavioral and neuropsychiatric symptom scores, and recorded adverse events collected during the trial. All personal identifiers will be removed to ensure full anonymization. The dataset includes only variables used for analysis of primary and secondary outcomes. The data file will be provided in an encrypted format and structured in a standardized manner. When: Access to the de-identified dataset will begin six months after publication of the main study results and will remain available for at least five years following the publication date. To whom: Researchers affiliated with universities, medical research centers, or recognized scientific institutions who have an approved research proposal related to the study topic may request access. Applicants must demonstrate relevant research experience. Conditions: The data may be used exclusively for research purposes, secondary scientific analyses, or replication of study findings. Use of the data for commercial purposes or any attempt to re-identify participants is prohibited. Applicants must provide a detailed research proposal, a confidentiality agreement, and a formal commitment not to attempt participant re-identification. Any secondary publication must cite the original dataset source. Where to obtain: Requesters can send their application along with a brief proposal in Persian or English to the official email address of the Principal Investigator at [ManteghiA@mums.ac.ir]. The requester's name and institutional affiliation must be clearly stated. How to obtain: Upon receiving a request, an initial review will be completed within five working days. If the research topic is appropriate, the applicant will be asked to submit a research proposal, a data confidentiality agreement, and a commitment not to attempt participant re- identification. After verification of all documents, the encrypted dataset will be shared within 10 to 15 working days. The entire process typically takes between two to four weeks Comments:
public Farshad Abedi Torbati
School of Pharmacy, Mashhad university of medical science, Azadi square, Mashhad
Mashhad Central African Republic 9177948954 00985131801191 Abeditf@mums.ac.ir Mashhad University of Medical Sciences scientific Farshad Abedi
School of Pharmacy, Mashhad university of medical science, Azadi square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1589 Abeditf@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of bipolar 1 disorder in the acute manic phase (Based on DSM-5) Age 18 to 75 (both sexes included) YMRS total score 20 or greater at baseline Ability to participate in clinical evaluations Ability to provide written informed consent prior to any study-related procedures 18 years 75 years Both Pregnancy or lactation Presence of intellectual disability or severe cognitive impairment A predominant comorbid psychiatric disorder that may confound the primary diagnosis Hepatic failure (ALT/AST > 3xULN) Thrombocytopenia (PLT< 100000) Use of amphetamine-type substances Second or third- degree heart block History of hypersensitivity reaction to Lacosamide or Valproate F30 Manic episode Treatment - Drugs Treatment - Drugs Control group: Treatment with valproate is initiated at a dose of 200 mg three times daily and titrated over 2 weeks to reach a target dose of 20 mg/kg/day. Patients will be assessed at baseline (admission), and on Day 3, Week 1, and Week 2 using the YMRS and CGI, administered by a resident physician through patient interview. In addition, all patients will receive standard-of-care treatment with risperidone. Intervention group: Treatment is initiated at a starting dose of 50 mg/day and gradually titrated up to 200–300 mg/day. Patients will be assessed at baseline (admission), and on Day 3, Week 1, and Week 2 using the YMRS and CGI scales, administered by a resident physician through patient interview. In addition, all patients will receive standard-of-care treatment with risperidone. Change in Young Mania Rating Scale (YMRS ) Score. Timepoint: Baseline (study entry) and on Days 3, 7, and 14. Method of measurement: Structured clinical interview. Change in CGI-S (Clinical Global Impression – Severity) Score. Timepoint: Baseline (study entry) and on Days 3, 7, and 14. Method of measurement: Structured clinical interview. Adverse Events: Assessment method: Adverse event checklist and laboratory monitoring of renal function, hepatic function, and blood cell counts. Timepoint: Baseline and on study day 14. Method of measurement: Based on the drug monograph of UptoDate, administered by trained personnel (clinical pharmacist/nurse). Mashhad University of Medical Sciences Approved 2026-04-25 Ethics Committee of Mashhad University of Medical Sciences School of Medicine, East Gate of the University Campus, Azadi Square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)