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A Comparison of the Anti-Anxiety Effects of Oral Ketamine and Fluvoxamine in Children with Separation Anxiety Disorder Manifesting as School Refusal

Afsaneh Karbasi Amel, Farzaneh Hosseini

Advanced Biomedical Research April 1, 2023 DOI: 10.4103/abr.abr_388_22 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open-label randomized clinical trial Peer reviewed
Sample size 71
Population Children aged 6-10 years diagnosed with school-refusal separation anxiety disorder
Interventions Ketamine Fluvoxamine
Dose Ketamine: weekly rising dose of 0.1 to 1 mg/kg; Fluvoxamine: 25 mg/day, could increase to 200 mg/day if necessary
Duration 16 weeks of intervention, with assessments before treatment and at weeks 8 and 16
Measures SCARED, CATS
Topics Anxiety Esketamine Ketamine
Citations 5
Key findings Ketamine reduced mean anxiety scores from 31.5 at baseline to 19.7 by week 8, with no further improvement by week 16 (19.4), whereas fluvoxamine showed no significant change at week 8 (36.3 to 36.9) but a significant reduction by week 16 (26.2). The authors conclude ketamine was more successful than fluvoxamine in the first eight weeks and recommend considering combination therapy in early treatment.

Abstract

Background: Children suffer from a high prevalence of anxiety problems that require prompt treatment. It has been demonstrated that ketamine offers rapid anti-anxiety effects. This study aimed to evaluate ketamine's anti-anxiety impact in the treatment of children with school-refusal separation anxiety disorder.

Materials and Methods: In this open-labeled randomized clinical trial, 71 children (6-10 years) diagnosed with school refusal separation anxiety disorder were randomly assigned to two groups; a case group, who received ketamine at a weekly rising dose of 0.1 to 1 mg/kg; the control group treated with Fluvoxamine (25 mg/day), which could increase to 200 mg/day if necessary. The SCARED and CATS questionnaires were used to assess anxiety before treatment, at the 8 th and 16 th weeks of intervention. The data were analyzed using repeated-measures analysis of covariance.

Results: The mean anxiety scores in the eighth week (19.7 ± 16.1) were significantly lower in the ketamine group than before (31.5 ± 10.8). Until the sixteenth week (19.4 ± 14.6), there was no further decrease in scores in the ketamine group, in the fluvoxamine group, pre-treatment scores (36.3 ± 16.5) and eighth week (36.9 ± 16.6) were not significantly different, but scores decreased significantly in a sixteenth week (26.2 ± 12.5).

Conclusion: In first eight weeks of treatment, ketamine was more successful than fluvoxamine at reducing anxiety disorder, considering the emergence of this disorder and the lack of major adverse effects of ketamine, it seems to be beneficial in early phases of treatment. Due to the quick onset of ketamine in future trials, their combination therapy is recommended during the initial weeks of treatment.

Comparable studies

Other randomized controlled trials on ketamine for anxiety, most cited first.

Study Year Design Participants
Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial Patients with mood and anxiety spectrum disorders who presented with clinically... 2015 Randomized controlled trial n = 24
Single Versus Repeated Sessions of Ketamine-Assisted Psychotherapy for People with Heroin Dependence Detoxified inpatients with heroin dependence 2007 Randomized controlled trial n = 59
Effects of ketamine in patients with treatment-refractory generalized anxiety and social anxiety disorders: Exploratory double-blind psychoactive-controlled replication study Patients with treatment-resistant generalized anxiety and social anxiety disorders who... 2020 Double-blind, psychoactive-controlled ascending dose study n = 12
Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind, Active-controlled Trials of Esketamine Nasal Spray Combined With a New Oral Antidepressant Patients with treatment resistant depression 2020 Randomized controlled trial
Efficacy of intravenous ketamine treatment in anxious versus nonanxious unipolar treatment-resistant depression Subjects with treatment-resistant depression 2018 Randomized controlled trial n = 99

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