Trial reportBMC psychiatry2016
Circadian rest-activity rhythms during benzodiazepine tapering covered by melatonin versus placebo add-on: data derived from a randomized clinical trial.
Trial report in BMC psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01431092 (Prolonged-release Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.
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.
Prolonged-release Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia: a Randomized Clinical Trial
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Prevalence and risk factors for misuse of prescription psychotropic drug in patients with severe mental illness: A systematic review.Actas espanolas de psiquiatria · 2023Pooled it
- Actigraphy studies and clinical and biobehavioural correlates in schizophrenia: a systematic review.Journal of neural transmission (Vienna, Austria : 1996) · 2019Pooled it
- Rest-Activity Rhythm Patterns and Their Associations With Depression and Obesity: A Study Using Actigraphy and Human-Smartphone Interactions.Depression and anxiety · 2025Article
- Effects of Approved Pharmacological Interventions for Insomnia on Mood Disorders: A Systematic Review.Clinical neuropsychiatry · 2024Review
- Review
- Social zeitgebers and circadian dysrhythmia are associated with severity of symptoms of PTSD and depression in trauma-affected refugees.European archives of psychiatry and clinical neuroscience · 2021Article
- Review
- Therapeutic use of melatonin in schizophrenia: A systematic review.World journal of psychiatry · 2021Article
- Validity of a Novel Research-Grade Physical Activity and Sleep Monitor for Continuous Remote Patient Monitoring.Sensors (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with severe mental illness often suffer from disruptions in circadian rest-activity cycles, which might partly be attributed to ongoing psychopharmacological medication. Benzodiazepines are frequently prescribed for prolonged periods despite recommendations of only short-term usage. Melatonin, a naturally occurring nocturnal hormone, has the potential to stabilize disrupted circadian rhythmicity. Our aim was to investigate how prolonged-release melatonin affects rest-activity patterns in medicated patients with severe mental illness and if benzodiazepine dose reduction is associated with changes in circadian rhythm parameters.
methodData were derived from a randomized, double-blinded clinical trial with 24 weeks follow-up. Participants were randomized to add-on treatment with prolonged-release melatonin (2 mg) or matching placebo, and usual benzodiazepine dosage was gradually tapered. Here we report the results of 72 h of actigraphic assessment of activity-rest cycles performed pre and post tapering. Changes in rest-activity rhythm parameters between the melatonin and placebo group were analyzed using the univariate general linear model. Change in activity counts per 6 h, from baseline to follow-up, in the whole sample was analyzed using paired samples t-test.
resultsA subsample of 48 patients participated in the actigraphic assessment: 20 in the melatonin group and 28 in the placebo group. Rest-activity cycles varied from regular to highly disrupted. Melatonin significantly increased the interdaily stability and at a trend level decreased the intradaily variability compared with placebo. Benzodiazepine dose reduction was not associated with these circadian rhythm parameters. Activity counts were generally higher after benzodiazepine dose reduction compared with pre tapering, but differences did not reach statistical significance.
conclusionOur data suggest melatonin as an aid during benzodiazepine withdrawal for patients distressed by disrupted circadian rest-activity cycles. Benzodiazepine tapering might result in diminished sedentary behavior but further research is needed.
trial registrationClinicalTrials NCT01431092 , clinicaltrials.gov. Registered 31 August 2011.
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