About this trial
This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Physically healthy
willing and able to provide informed consent (if under 18 also parent or guardian consent)
A definite diagnosis of DSM-5
a Children's Depression Rating Scale-Revised (CDRS-R) score >=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score >=4 rated over the last two weeks.
Disqualifiers
Pregnancy or lactation
post-partum state (being within 2 months of delivery or miscarriage);
homicide risk as determined by clinical interview
any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine/caffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa.
Trial design
Single group
Treatments tested in this trial
Genetic testing
GeneticAttempting to identify the genetic biomarker that can identify risk for suicidal ideation and action
Treatment groups
Trial outcomes
Primary outcomes
Clinical phenotype analysis
Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator