BackgroundLittle attention has been given to efficacious treatment and adherence to treatment of compulsive sexual behavior (CSB).AimsRandomized controlled trial investigated short-term psychodynamic group therapy followed by relapse prevention group (STPGP-RPGT) and pharmacological treatment (PT) for CSB men on sexual compulsivity and adherence.Method135 men, 38 (SD = 9) years old on average, were randomly assigned to 1) STPGP-RPGT; 2) PT; 3) Both. Participants completed measures at baseline, 25th, and 34th week. 57 (42.2%) participants dropped out between baseline and 25th week, and 68 (50.4%) between baseline and 34th week. 94 (69.6%) did not adhere (80% pills taken or attended 75% therapy sessions).ResultsA significant interaction effect was found between time and group (F (4, 128) = 2.62, P = 0.038, ES = 0.08), showing who received PT improved less in sexual compulsivity than those who received STPGP-RPGT (t = 2.41; P = 0.038; ES = 0.60) and PT + STPGP-RPGT (t = 3.15; P = 0.007, ES = 0.74). Adherent participants improved more in sexual compulsivity than non-adherent at the 25th week (t = 2.82; P = 0.006, ES = 0.65) and 34th week (t = 2.26; P = 0.027, ES = 0.55), but there was no interaction effect, F (2, 130) = 2.88; P = 0.06; ES = 0.04). The most reported behavior (masturbation) showed greater risk of non-adherence (72.6%).Discussion and conclusionsAdherent participants improved better than non-adherent. Participants who received psychotherapy improved better than those who received PT. Methodological limitations preclude conclusions on efficacy.
ObjectiveKetamine, an N-methyl D-aspartate (NMDA) receptor antagonist, can promote rapid action in the management of individuals with treatment-resistant depression (TRD) at sub-anesthetic doses. However, few studies have investigated the long-term use of ketamine administered intravenously (IV) and intranasally (IN). We report the design and rationale of a therapeutic trial for assessing the efficacy, safety, and tolerability of repeated-dose intramuscular (IM) ketamine vs. active treatment (escitalopram and aripiprazole) in TRD patients.MethodsA comparative, parallel-group, randomized double-blind trial assessing the efficacy, safety, and tolerability of acute (4 weeks) and maintenance (24 weeks) use of IM ketamine (0.75 mg/kg) vs. active control (escitalopram 15 mg and aripiprazole 5 mg) in individuals with moderate-severe intensity TRD (no psychotic symptoms) with or without suicide risk will be conducted. Patients with TRD (18–40 years) will be randomized and blinded to receive ketamine IM or active treatment at a 1:1 ratio for 4 weeks (active treatment) and 24 weeks (maintenance treatment). Subjects will be assessed using clinical scales, monitored for vital signs (VS) after application of injectable medication, and undergo neuropsychological tests. The primary outcome will be changed on the Montgomery-Åsberg Depression Rating Scale (MADRS) during the course of the trial. The study is in running.ResultsThis study can potentially yield evidence on the use of IM ketamine in the treatment of depressive disorders as an ultra-rapid low-cost therapy associated with less patient discomfort and reduced use of medical resources, and can elucidate long-term effects on different outcomes, such as neuropsychological aspects.ConclusionsThe trial can help promote the introduction of a novel accessible approach for the treatment of complex disease (TRD) and also allow refinement of its long-term use.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04234776, identifier: NCT04234776.
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