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The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial.

ABSTRACT: Depression following acute coronary syndrome (ACS) constitutes a serious and debilitating problem. Approximately one in five patients will develop significant depression following ACS and less severe depressive symptoms are even more frequent. Furthermore, anxiety symptoms and sleep-wake disturbances are frequent. The objective of the MEDACIS trial is to investigate whether prophylactic treatment with melatonin has a preventive effect on depression, depressive and anxiety symptoms, sleep, and circadian disturbances following ACS."The effect of MElatonin and Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome" trial (MEDACIS) is a multicenter, double-blinded, placebo-controlled, randomized clinical trial. A total of 240 patients with ACS and no depressive symptoms will be included in the trial for treatment with either 25 mg melatonin or placebo for a 12-week period. Development and severity of depressive symptoms will be evaluated using Major Depression Inventory every 2 weeks with the purpose of investigating the potential preventive effect of melatonin on depressive symptoms.Previously, only selective serotonin reuptake inhibitors (SSRIs) have been investigated in a primary preventive setup in patients following ACS. However, SSRIs are associated with several side effects. An ideal intervention would constitute the highest degree of prevention of depressive symptoms with the lowest risk of side effects. In this regard, melatonin may have advantages due to its low toxicity as well as its proven anxiolytic and hypnotic effects.ClinicalTrials.gov, Identifier: NCT02451293 . Registered on 12 May 2015. EudraCT nr. 2015-002116-32.

SUBMITTER: Madsen MT

PROVIDER: S-EPMC5322602 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial.

Madsen Michael Tvilling MT Isbrand Anders A Andersen Ulla Overgaard UO Andersen Lars Juel LJ Taskiran Mustafa M Simonsen Erik E Gögenur Ismail I

Trials 20170223 1

<h4>Background</h4>Depression following acute coronary syndrome (ACS) constitutes a serious and debilitating problem. Approximately one in five patients will develop significant depression following ACS and less severe depressive symptoms are even more frequent. Furthermore, anxiety symptoms and sleep-wake disturbances are frequent. The objective of the MEDACIS trial is to investigate whether prophylactic treatment with melatonin has a preventive effect on depression, depressive and anxiety symp ...[more]

PMID: 28228148

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Project description:Disturbed sleep is a common subjective complaint among individuals with anxiety disorders. Sleep deprivation increases general and specific anxiety symptoms among healthy individuals. The amygdala is critical for regulating anxiety and also involved in mediating the effects of emotions on sleep. Neuropeptide S (NPS) and NPS receptors (NPSR) are reported as a novel endogenous arousal and anxiolytic system, but it is unclear yet whether this system is involved in anxiety-like behavior and sleep caused by sleep deprivation, and how it plays anxiolytic effect underlying the comorbid condition. In the present study, we demonstrate that paradoxical sleep deprivation (PSD) induced by modified multiple platform method (MMPM) for 24 h caused anxiety-like behavior, a prolonged sleep latency and subsequent paradoxical sleep (PS) rebound accompanied by an increase in electroencephalogram (EEG) theta (4.5-8.5 Hz) activities across light and dark phase in rats. The increase of PS after PSD was due to an increase of episode number during light phase and both episode number and duration during dark phase. Central action of NPS (1 nmol) attenuated PSD-induced anxiety-like behavior, and altered PSD-induced sleep-wake disturbances through increasing wakefulness, and suppressing PS and EEG theta activities. The reduction in PS time following NPS administration during light phase was because of a decreased episode number. Furthermore, sleep amount in 24 h in PSD rats given NPS was lesser than that given saline. PSD significantly enhanced NPSR mRNA expression level in the amygdala. NPS remarkably increased the number of Fos-ir neurons in the basolateral amygdala (BLA), the central amygdala (CeA) and medial amygdala (MeA). The majority of Fos-ir neurons induced by NPS also expressed NPSR. These results suggest that NPSR upregulation in the amygdala is presumably related to the PSD-induced anxiety-like behavior and sleep disturbances, and that NPS counteracts PSD-induced anxiety-like behavior and sleep disturbances possibly through activating the neurons bearing NPSR in the amygdala. In addition, the little sleep increase in PSD rats treated with NPS suggests that NPS can function as an anxiolytic without causing a subsequent sleep rebound.

Project description:BACKGROUND:Several studies point to a correlation between obesity and the severity of depressive and anxiety symptoms in children and adults, but there are still some controversial points about this association. The aim of this study is to investigate the relationship between body composition and the severity of anxiety/depressive symptoms in overweight and obese individuals with Metabolic Syndrome (MS). METHODS:Fifty patients, 18-50 years old, overweight or obese and with the diagnosis of MS based on the International Diabetes Federation (IDF) criteria were selected for this study. Body composition was evaluated using Dual Energy X-ray Absorptiometry (DXA). Depressive symptoms were evaluated using the Hospital Anxiety and Depression Scale (HADS-Depression) and the Beck Depression Inventory (BDI). Anxiety symptoms were evaluated using HADS-Anxiety. RESULTS:No correlation was found between depressive symptoms (HADS-Depression or BDI) and Body Mass Index (BMI) (r?=?0.01; p?=?0.94 and r?=?-0.12, p?=?0.38; respectively), Waist Circumference (WC) (r?=?-0.06, p?=?0.67 and r?=?-0.22, p?=?0.12; respectively), and Waist-to-Hip Ratio (WHR) (r?=?-0.12, p?=?0.40 and r?=?-0.17, p?=?0.23; respectively). Additionally, no correlation was found among anxiety symptoms (HADS-Anxiety) and BMI (r?=?-0.15, p?=?0.27), and WHR (r?=?-0.17, p?=?0.24). In contrast, a significant correlation was found between percentage of total fat (DXA) and HADS-Depression (r?=?0.34, p?=?0.019) and HADS-Anxiety (r?=?0.30, p?=?0.039). Additionally, an inverse and strong correlation was found between lean mass (in grams) and HADS-Depression (r?=?-0.42, p?=?0.004), HADS anxiety (r?=?-0.57, p?<?0.0001), and BDI (r?=?-0.44, p?=?0.026). CONCLUSIONS:In individuals with MS, the percentage of body fat, and not central fat, BMI, WC, or WHR, was associated with an increased severity of anxiety and depressive symptoms. In contrast, total lean mass was strongly associated with fewer anxiety/depressive symptoms, suggesting that body composition might be related to psychiatric comorbidity in overweight individuals with MS.

Dataset Information

The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial.

Publications

The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial.

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