Multimodal clinical, sleep, and autonomic correlates across the depressive spectrum: a cross-sectional study
Article excerpt
Depression is a heterogeneous condition characterized by affective symptoms, sleep disturbance, and altered physiological regulation, but the relative contribution of subjective and objective measures to depressive status remains unclear. In this cross-sectional study, 101 participants were categorized as healthy controls…
Introduction Mental health is now recognised as a major global concern affecting people from diverse backgrounds. There is growing evidence that the gut microbiota plays a crucial role by producing metabolites that significantly influence a person’s mood and behaviour. Despite its importance, there is a significant gap in the profiling and understanding of the gut microbiota’s influence on mental health among Malaysians. Therefore, this study aims to determine gut microbiome profiles among patients with major depressive disorders (MDD) of different treatment groups attending psychiatric clinics in the state hospitals and compare them to healthy individuals in the community of Klang Valley, Malaysia.
Methods and analysis This cross-sectional study will be carried out in Klang Valley, Malaysia. Eligibility of the patients will be assessed by the psychiatrists prior to recruitment of patients. Patients with MDD will be categorised into monotherapy and polypharmacy while healthy individuals will be used as a comparison group. Demographic data will be recorded. Stool samples will be subjected to DNA extraction and 16S rRNA gene-sequencing analysis to determine the microbial compositions of the gut microbiome.
Ethics and dissemination This study will be conducted following the procedure set by the National Medical Research Register Malaysia. The Medical Research Ethics Committee (MREC), Ministry of Health Malaysia, has ratified this study and granted ethical approval to conduct this study (NMRR ID-22-00893-JVW). All the participants will be given an information sheet and will sign a consent form to participate. Participants have the right to withdraw from the study at any time without an explanation. All information gathered will be used for research purposes only and treated as confidential. The results will be submitted to peer-reviewed journals for publication as well as presented at national and international conferences. Informing policy makers at all levels is a crucial aspect of the dissemination and will be done from local to international levels.
Trial registration number This study was registered under National Medical Research Register Malaysia (NMRR ID-22-00893-JVW), a mandatory procedure of the Ministry of Health Malaysia before the start of a research.