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Naproxen Adjunct to Fluoxetine for Moderate-To-Severe Obsessive-Compulsive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial Publisher Pubmed



Shamabadi A1 ; Motavalian Z1 ; Farahmand Y1 ; Farahmand K1 ; Arabzadeh Bahri R1 ; Askari S2 ; Ansari S3 ; Fallahzadeh M1 ; Shalbafan M2 ; Akhondzadeh S1
Authors
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Authors Affiliations
  1. 1. Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Mental Health Research Center, Psychosocial Health Research Institute, Department of Psychiatry, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
  3. 3. Psychosomatic Research Center, Tehran University of Medical Sciences, Tehran, Iran

Source: Psychiatry and Clinical Neurosciences Published:2024


Abstract

Aim: Current treatments for obsessive-compulsive disorder (OCD) encounter resistance and limiting adverse events, necessitating novel therapeutic strategies. This study aimed to investigate the benefits of naproxen, a medication with effects on inflammation and neuronal function, on OCD. Methods: One hundred and four OCD outpatients with a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of >21 were equally assigned to receive fluoxetine plus either naproxen 250 mg or matched placebo q12hr. Patients were assessed using the Y-BOCS by recording the subscale scores at baseline and weeks 5 and 10 to evaluate efficacy. They were also assessed in terms of tolerability. Results: Data from 96 patients were analyzed. The baseline characteristics were comparable between the groups. There were significant time-treatment interaction effects on the obsession subscale ((Formula presented.) = 0.055) and total ((Formula presented.) = 0.043) scores of Y-BOCS. Reductions in the obsession subscale and total scores of Y-BOCS were significantly greater in the fluoxetine plus naproxen group until the endpoint (Cohen's d = 0.560 and Cohen's d = 0.477, respectively). However, the difference in compulsion subscale score changes between the groups was not significant. Respondents with a reduction of ≥35% in Y-BOCS total scores were significantly more in the fluoxetine plus naproxen group (80.0% versus 47.8%). The side effect frequencies were comparable between the groups. Conclusion: Naproxen, adjunct to fluoxetine, outperformed adjunctive placebo in treating obsession and total symptoms of OCD patients in a safe and tolerable manner. Clinical trial registration: The study protocol was registered and published in the Iranian Registry of Clinical Trials (http://www.irct.ir; registration number IRCT20090117001556N139). © 2024 The Author(s). Psychiatry and Clinical Neurosciences © 2024 Japanese Society of Psychiatry and Neurology.
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