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IRCT20260426069173N1 IRCT 2026-06-20 Shiraz University of Medical Sciences Investigating the Effect of Agomelatine in Obsessive-Compulsive Disorder Investigating the Effect of Agomelatine as an Adjunctive Treatment in Obsessive-Compulsive Disorder: A Double-Blind Randomized Controlled Drug Trial 2026-04-30 anticipated 70 Recruiting https://irct.ir/trial/89671 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The unit of randomization is the individual participant. Eligible participants will be randomly allocated in a 1:1 ratio to the intervention or control group after obtaining informed consent and definite enrollment in the study. Block randomization will be used, and no stratified randomization will be applied. The random allocation sequence will be generated by the principal investigator using computer-generated random numbers in SPSS. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. The envelopes will be used according to the order of participant enrollment, and each envelope will be opened only after the patient is definitely enrolled in the study. Before opening the envelope, the allocation sequence will not be accessible to the participant, the outcome assessor, or the main study collaborator, Blinding description: This study will be conducted as a double-blind trial. Participants and outcome assessors will be unaware of group allocation and the type of intervention, agomelatine or placebo. The active drug and placebo will be identical in appearance, color, and packaging. The data analyst will also remain blinded to group allocation until the analysis is completed. The principal investigator will be aware of liver function test results for safety monitoring. 3 Obsessive-compulsive disorder. Intervention 1: Intervention group: Intervention group: Patients will receive escitalopram starting at 5 mg daily, which may be increased by 5 mg weekly if needed up to a maximum of 30 mg daily. In addition, they will receive agomelatine 25 mg daily for 16 weeks. Both drugs will be supplied by Tadbirkala Company. Intervention 2: Control group: Control group: Patients will receive escitalopram starting at 5 mg daily, which may be increased by 5 mg weekly if needed up to a maximum of 30 mg daily. In addition, they will receive a placebo identical to agomelatine for 16 weeks. Both drugs will be supplied by Tadbirkala Company. No - There is not a plan to make this available Justification or reason for not sharing IPD is Individual participant data will not be publicly shared due to the confidentiality of mental health information and the possibility of indirect identification of participants. Study results will be published only in aggregate form without identifiable information
public Leila Razeghian Jahromi
Km 13, Shiraz-Isfahan Highway, Opposite Niayesh Township, Ostad Moharreri Psychiatric Hospital
Shiraz Iran (Islamic Republic of) 71441-13331 +98 71 3260 5701 leilarazeghian1366@gmail.com Shiraz University of Medical Sciences scientific Leila Razeghian Jahromi
Km 13, Shiraz-Isfahan Highway, Opposite Niayesh Township, Ostad Moharreri Psychiatric Hospital
Shiraz Iran (Islamic Republic of) 71441-13331 +98 71 3260 5701 leilarazeghian1366@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 60 years Diagnosis of obsessive-compulsive disorder based on DSM-5 criteria Y-BOCS score equal to or greater than 18 Written informed consent to participate in the study Ability to attend follow-up visits and complete study questionnaires 18 years 60 years Both Presence of a life-threatening medical condition or neurological disorder Presence of comorbid psychiatric disorder History of substance abuse Pregnancy or breastfeeding Intellectual disability History of severe hypersensitivity or contraindication to agomelatine or escitalopram History of complete treatment with escitalopram History of surgical treatment for obsessive-compulsive disorder Treatment-resistant obsessive-compulsive disorder Use of psychotropic medications during the 6 weeks before study entry Concurrent participation in other studies or psychotherapy during the study Hepatic failure or elevated liver enzymes F42 Obsessive-compulsive disorder Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Patients will receive escitalopram starting at 5 mg daily, which may be increased by 5 mg weekly if needed up to a maximum of 30 mg daily. In addition, they will receive agomelatine 25 mg daily for 16 weeks. Both drugs will be supplied by Tadbirkala Company. Control group: Control group: Patients will receive escitalopram starting at 5 mg daily, which may be increased by 5 mg weekly if needed up to a maximum of 30 mg daily. In addition, they will receive a placebo identical to agomelatine for 16 weeks. Both drugs will be supplied by Tadbirkala Company. Change in severity of obsessive-compulsive symptoms based on the Y-BOCS score. Timepoint: The test score will be measured at baseline before starting the intervention, and then at the end of weeks 4, 8, and 16 after starting the therapeutic intervention with escitalopram and agomelatine. Method of measurement: Symptom severity will be measured using the Yale-Brown Obsessive Compulsive Scale. This scale includes 10 items, each scored from 0 to 4. Higher scores indicate greater symptom severity. Occurrence of adverse drug effects including headache, dizziness, drowsiness, gastrointestinal adverse effects, and skin adverse effects. Timepoint: Adverse drug effects including headache, dizziness, drowsiness, gastrointestinal adverse effects, and skin adverse effects will be assessed at the end of weeks 4, 8, and 16 after starting the therapeutic intervention. Method of measurement: Adverse drug effects including headache, dizziness, drowsiness, gastrointestinal adverse effects, and skin adverse effects will be recorded using an adverse drug effect questionnaire. Change or elevation in liver enzymes. Timepoint: Liver enzymes will be measured at baseline before starting the intervention and then at the end of weeks 4, 8, and 16 after starting the therapeutic intervention. Method of measurement: Liver enzymes will be measured by blood tests and liver function tests. Shiraz University of Medical Sciences Approved 2026-02-21 Ethics Committee of Shiraz University of Medical Sciences Km 13, Shiraz-Isfahan Highway, Opposite Niayesh Township, Ostad Moharreri Psychiatric Hospital Shiraz Fars Iran (Islamic Republic of)