Epigenetic Biomarkers of Suicidal Ideation

PURPOSE: To investigate longitudinal changes in epigenetic markers (i.e., genome-wide DNA methylation levels) in patients during an acute suicidal episode and after its resolution. We will collect clinical information and biological samples from inpatients presenting with suicidal behavior during acute symptoms and immediately before hospital discharge, ultimately generating a repository of samples for the interrogation of epigenetic biomarkers and their clinical relevance in this and future projects. Target enrollment is 200 subjects within two years.

PROCEDURES: Only subjects meeting inclusion criteria who agree to this study and provide voluntary written consent will be permitted to participate. The study will be explained to the subjects, including benefits and risks, and all their concerns and questions will be addressed prior to enrollment. Participation in this protocol is voluntary and will be for research purposes only, not part of routine standard of care. Research staff will perform ALL study related tasks, including blood sample collections. Participation will not interfere with clinical care in any way.

This study involves two visits: 1) while patients are experiencing acute suicidal ideation, and 2) after SI symptom resolution. During both visits, research staff will conduct structured interviews with patients in a secure, private location on that patient’s assigned unit (e.g., an available treatment/exam room) and collect blood samples (approx.. 34mL) for later epigenetic analysis. All patient information is completely de- identified (according to HIPAA requirements) and stored in a secure location. Prior to discharge, subjects will receive monetary compensation for their participation.

Research personnel will administer the following scales:

• Demographics form;
• Suicide history section (adapted from Suicide History Form);
• Barratt Impulsiveness Scale (BIS);
• Beck Scale for Suicidal Ideation (SSI);
• Columbia-Suicide Severity Rating Scale (C-SSRS);
• Montgomery-Äsberg Depression Rating Scale (MADRS);
• Young Mania Rating Scale (YMRS)

IRB #: HSC-MS-21-0320

Participant Inclusion Criteria

·   Age 18 – 65 years, voluntary admission ·   Able to provide written informed consent in English ·   Diagnosis of a mood disorder with any current mood state (with or without comorbid diagnoses) ·   Current suicidal ideation (per SSI score >4 and CSSRS score >4)

Participant Inclusion Criteria

·   Age 18 – 65 years, voluntary admission ·   Able to provide written informed consent in English ·   Diagnosis of a mood disorder with any current mood state (with or without comorbid diagnoses) ·   Current suicidal ideation (per SSI score >4 and CSSRS score >4)

PRIMARY STUDY CONTACTS:

Principal Investigator:	Study Coordinator (Primary contact):
Rodrigo Machado-Vieira MD, PhD Phone: 713-741-6047 Email: Rodrigo.MachadoVieira@uth.tmc.edu Office: HCPC 2E-57	Courtney Vecera Phone: 713-741-6043 Email: Courtney.Vecera@uth.tmc.edu Office: HCPC 3E-50