Suicidal Ideation
Conditions
Brief summary
Suicide is a major crisis worldwide with rates projected to continue to increase. There is currently a dearth of novel pharmacologic treatment options for suicide available on the market. The endocannabinoid system has been recently shown to be associated with mood disorders including suicidality. The aim of the study is to determine whether treatment with Nabilone is capable of reducing suicidal ideation in adults after 3 days.
Interventions
DRUGNabilone
Nabilone is a synthetic endocannabinoid and CB1 agonist.
DRUGPlacebo
Inactive placebo comparator
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent * Current suicidal ideation * Columbia Suicide Severity Rating Scale (CSSRS) score of ≥ 4 and Scale for Suicide Ideation (SSI) first 5 items, score of ≥4 * Current major depressive episode as evidenced by MADRS score ≥ 20
Exclusion criteria
* Current diagnosis of a Diagnostic and Statistical Manual V (DSM-V) psychotic disorder, psychotic symptoms, or personality disorder. * Recent (\<72 hrs) use of illicit substances * Comorbid substance use disorder diagnosis * Urine drug screen (UDS) positive for tetrahydrocannabinol (THC) * Pregnant or nursing women * Unstable medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicidal Ideation and Behavior as assessed by an abbreviated version of the Columbia-Suicide Severity Rating Scale (CSSRS) | baseline, day 3 | For the abbreviated, six-question version of the CSSRS, total scores range from 0 to 6 with a higher score indicating greater suicidal ideation and behavior. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | baseline, day 3 | The MADRS is a ten item instrument, with each of the ten items rated on a scale of 0 to 6, giving a total score range of 0 to 60. A higher score indicates greater depression. |
| Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI) | baseline, day 3 | The SSI is a nineteen item measure of current suicidal ideation and intention, with each item rated on a scale of 0 to 2, giving a total score range of 0 to 38. A higher score indicates greater suicidal ideation and intention. |
| Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) | baseline, day 3 | The GAD-7 is a seven item instrument, with each of the 7 items is scored from 0 to 3, giving a total score range of 0 to 21. A higher score indicates greater anxiety. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | baseline, day 3 | To determine whether treatment with Nabilone would lead to changes in the level of serum biomarkers and inflammatory cytokines; and their association with its antisuicidal and antidepressant effects. |
Countries
United States
Outcome results
None listed