Melatonin attenuates antipsychotic metabolic effects: an eight‐week randomized, double‐blind, parallel‐group, placebo‐controlled clinical trial

Romo‐Nava, Francisco; González, Dení Alvarez-Icaza; Fresán‐Orellana, Ana; Alvarez, Ricardo Saracco; Becerra‐Palars, Claudia; Moreno, Julia; Uribe, Martha Patricia Ontiveros; Berlanga, Carlos; Heinze, Gerhard; Buijs, Ruud M.

doi:10.1111/bdi.12196

Cited by 100 publications

(88 citation statements)

References 56 publications

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“…Allocation concealment was adequate in all trials, except in one,20) which did not report enough information to judge this methodological issue. In the study of Romo-Nava et al (2014),22) allocation was concealed by first generating random numbers for identical bottles labeled with this number. Numbers corresponded to randomly assigned placebo or melatonin groups in a 1:1 ratio, with information kept by a co-investigator that did not participate in patient recruitment or evaluation.…”

Section: Risk Of Biasmentioning

confidence: 99%

“…Data for this comparison was derived from three studies 13,22,23). Results from these three studies were pooled for meta-analysis.…”

Section: Intervention Effectsmentioning

confidence: 99%

“…In one study,13) participants were randomly allocated to receive either olanzapine 25 mg/day and melatonin 3 mg (active group) or olanzapine 25 mg/day and placebo (control group). In the second study,22) patients who had initiated continuous treatment with antipsychotics (clozapine, olanzapine, quetiapine, or risperidone) for a period no greater than three months prior to their inclusion in the study were allocated either 5 mg slow-release melatonin or placebo; results were then analyzed according to the metabolic risk of the anti-psychotics. To reduce methodological and clinical heterogeneity, we only considered data from patients receiving antipsychotics at high risk of metabolic disturbances (i.e., olanzapine and clozapine) when including results from this study in the meta-analysis.…”

Section: Intervention Effectsmentioning

confidence: 99%

“…The three trials were conducted in adolescents23) or adults13,22) affected by schizophrenia or bipolar disorders treated with olanzapine or clozapine. In these studies, participants had no concomitant medical or neurological illnesses and no known risk factors for metabolic disturbances.…”

Section: Intervention Effectsmentioning

confidence: 99%

“…(2014) 22). Patients treated with quetiapine or risperidone (antipsychotics with medium metabolic risk) allocated to melatonin showed a significant difference in mean change in DBP values compared with those allocated placebo (1.8 vs. −4.6 mmHg, respectively; p =0.008).…”

Section: Subgroup Analyses According To Agementioning

confidence: 99%

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Does Melatonin and Melatonin Agonists Improve the Metabolic Side Effects of Atypical Antipsychotics?: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Igwe

Brigo

2018

Clin Psychopharmacol Neurosci

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Atypical antipsychotics (AAPs) are increasingly used for the treatment of psychotic disorders but are known to be associated with metabolic abnormalities. This study is a systematic review and meta-analysis of randomized controlled trials (RCTs) studying the effectiveness of melatonin for the amelioration of AAP-induced metabolic syndrome. The MEDLINE (accessed via PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials, PsycINFO, LILACS, CINAHL, and OpenGrey databases were searched for RCTs without language restrictions. Inclusion criteria were randomized, double-blind clinical trials comparing melatonin or melatonin agonists with placebo for the amelioration of AAP-induced effects at any age with selected components of metabolic syndrome as outcome measures. Two reviewers independently selected articles and assessed quality using Cochrane risk of bias and concealment tools. Of 53 records, five RCTs were eligible for the systematic review and three for the meta-analysis. The meta-analyses showed no statistically significant difference in any anthropometric or metabolic variable considered. Analysis according to psychiatric diagnosis from one RCT showed significant decreases in diastolic blood pressure (5.5 vs. −5.7 mmHg for the placebo and melatonin groups, respectively; p=0.001), fat mass (2.7 vs. 0.2 kg, respectively; p=0.032), and triglycerides (D) (50.1 vs. −20 mg/dl, respectively; p=0.08) in the bipolar group but not the schizophrenia group. Although limited to five RCTs with small sample sizes, evidence from RCT indicates that melatonin improves AAP-induced metabolic syndrome. This beneficial effect seems more significant in patients with bipolar disorder than those with schizophrenia. Further RCTs are needed to definitively establish the potential ameliorative effect of melatonin and to justify its efficacy as an add-on therapy to curtail AAP-induced metabolic syndrome.

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Section: Risk Of Biasmentioning

confidence: 99%

“…Data for this comparison was derived from three studies 13,22,23). Results from these three studies were pooled for meta-analysis.…”

Section: Intervention Effectsmentioning

confidence: 99%

Section: Intervention Effectsmentioning

confidence: 99%

Section: Intervention Effectsmentioning

confidence: 99%

Section: Subgroup Analyses According To Agementioning

confidence: 99%

See 3 more Smart Citations

Does Melatonin and Melatonin Agonists Improve the Metabolic Side Effects of Atypical Antipsychotics?: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Igwe

Brigo

2018

Clin Psychopharmacol Neurosci

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Melatonin and melatonin‐agonists for metabolic syndrome components in patients treated with antipsychotics: A systematic review and meta‐analysis

Miola

Fornaro

Sambataro

et al. 2021

Human Psychopharmacology

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Objective: Metabolic side effects are a limiting factor in the use of antipsychotics, which remain the cornerstone of long-term management of patients with severe mental illness. There is contrasting evidence on a possible role of melatonin and melatonin-agonists in attenuating antipsychotic-induced metabolic abnormalities. Design:We conducted a systematic review (PubMed, PsycInfo, Cochrane databases, up to August 2020) and a random-effect meta-analysis of double-blind, randomized placebo-controlled trials (RCTs) involving melatonin and melatonin-agonists in the treatment of antipsychotic-induced metabolic changes. The primary outcome was the standardized mean difference (SMD) of composite metabolic outcomes built with metabolic syndrome components. Secondary outcomes were individual metabolic syndrome components, and other anthropometric, glucose metabolism, lipid profile, and psychopathology measures.Results: Out of the initial 41 studies, six documented five separate RCTs randomizing 248 patients (126 to melatonin/ramelteon, 122 to placebo) affected by schizophrenia-spectrum disorders and bipolar disorder. Melatonin/ramelteon outperformed placebo on the primary outcome (SMD −0.28, 95% CI = −0.39 ÷ −0.168), as well as on all individual components of metabolic syndrome (systolic blood

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Cytoprotection by Melatonin: The Metabolic Syndrome as an Example

Cardinali

Vigo

2021

Psychiatry and Neuroscience Update

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Melatonin attenuates antipsychotic metabolic effects: an eight‐week randomized, double‐blind, parallel‐group, placebo‐controlled clinical trial

Cited by 100 publications

References 56 publications

Does Melatonin and Melatonin Agonists Improve the Metabolic Side Effects of Atypical Antipsychotics?: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Does Melatonin and Melatonin Agonists Improve the Metabolic Side Effects of Atypical Antipsychotics?: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Melatonin and melatonin‐agonists for metabolic syndrome components in patients treated with antipsychotics: A systematic review and meta‐analysis

Cytoprotection by Melatonin: The Metabolic Syndrome as an Example

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