Trial reportBMJ mental health2026
Randomised controlled trial of fluoxetine versus naltrexone in compulsive sexual behaviour disorder.
Trial report in BMJ mental health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
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Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCompulsive sexual behaviour disorder (CSBD), characterised by preoccupation with and loss of control over sexual behaviours, is associated with negative consequences in several areas of life. Evidence for pharmacological treatment remains limited, with only two previous randomised controlled trials and no studies comparing fluoxetine and naltrexone.
objectiveTo investigate whether naltrexone was more efficient and tolerable than fluoxetine in the treatment of CSBD.
methodsIn this open-label superiority trial, 80 participants diagnosed with CSBD according to International Classification of Diseases-11 criteria were randomly assigned (1:1) to receive fluoxetine (starting dose 20 mg/day) or naltrexone (starting dose 25 mg/day) for 8 weeks followed by 6 weeks without treatment. Symptom severity was recurringly assessed using the Hypersexual Disorder: Current Assessment Scale (HD:CAS). Linear mixed models were used for intention-to-treat and per-protocol analyses of treatment effects.
findings79 men and 1 woman were randomised to receive fluoxetine (n=40) or naltrexone (n=40). Analysis showed no statistically significant difference in HD:CAS score reduction between treatments at primary endpoint; naltrexone was not superior to fluoxetine. However, participants in the two treatment groups showed different patterns of symptom improvement over time.Two participants (5.1%) receiving fluoxetine were withdrawn due to adverse events (urticaria and elevated liver enzymes) and four participants (10.3%) discontinued treatment; six participants (15%) receiving naltrexone discontinued treatment.
conclusionsAlthough no statistically significant between-group difference was observed at week 8, symptom trajectories and adverse effect profiles differed between groups. CLINICAL IMPLICATIONS: Symptom-change patterns and adverse effect profiles may guide individualised treatment decisions.
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