Suicidal ideation
Conditions
Interventions
The Intervention group will receive a subcutaneous dose of 0.75mg / kg Dextrocetamine.
The control group will receive a subcutaneous dose of Midazolam 0.04mg / Kg, an active placebo that will provide
D007649
D008874
Sponsors
Universidade Federal de Santa Maria
Universidade Federal de Santa Maria
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Being admitted to the Psychiatric Inpatient Unit Paulo Guedes, of the University Hospital of Santa Maria / RS; Age between 18 and 80 years, of both sexes; Clinically significant suicidal ideation and score> = 4 in item 10 of the Montgomery-Asberg Depression Rating Scale; Women of childbearing potential must have a negative pregnancy test; Each patient or guardian must have a level of understanding sufficient to agree with all tests and examinations required by the protocol and must sign an informed consent form.
Exclusion criteria
Exclusion criteria: Presence of neurological diseases or neoplasms in activity and neurodegenerative diseases; Pregnant women and nursing mothers; Lifelong history of schizophrenia or primary psychotic disorder; Substance abuse or dependencies in the previous month; Simultaneous ECT course; Any unstable medical illness, including liver, kidney, gastroenterological, neurological, immunological or hematological diseases; Presence of any known or suspected contraindications to midazolam or ketamine, including, but not limited to, known allergic reactions to these agents or acute intermittent porphyria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistically significant decrease of suicidal ideation of those patients who were subjected to the administration of Dextrocetamine. For this, the Beck Suicide Ideation Scale (Beck Scale for Suicide Ideation — BSI) to be applied at the baseline (on the day before Dextrocetamine / Midazolam administration) will be used, 24, 48 and 72 hours after administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Dextrocetamine in reducing suicidal ideation in the medium term, assessed using the Beck Suicide Ideation Scale (Beck Scale for Suicide Ideation — BSI) to be applied 7 days and 1 month after the intervention.;Efficacy of Dextrocetamine in reducing depressive symptoms, measured using the Montgomery-Asberg Depression Scale (MADRS), 24h, 48h, 72h, 7 days and 1 month after the intervention.;Safety of subcutaneous Dextrocetamine administration, assessed through cardiac and respiratory monitoring (heart rate, peripheral oxygen saturation and blood pressure), to be performed for two hours after application.;General side effects, assessed using the Patient Rated Inventory of Side Effects (PRISE) symptom list, to be performed 60 minutes, 24h, 48h and one week after the intervention.;Dissociative symptoms, assessed using The Clinician Administered Dissociative States Scale (CADSS), 60 minutes after administration.;Mania symptoms, measured using the Young Mania Rating Scale (Young Mania Rating Scale – YMRS), 60 minutes after the intervention.;Psychotic symptoms, measured using the Brief Psychiatric Rating Scale (BPRS), 60 minutes after the intervention. | — |
Countries
Brazil
Contacts
Public ContactJoão Pacheco
Outcome results
None listed