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The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nabilone | Experimental | Patients in the treatment group will be administered oral Nabilone 2 mg once daily for 3 days in addition to treatment as usual according to current clinical guidelines and standard of care. |
|
| Placebo Comparator | Placebo Comparator | Patients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nabilone | Drug | Nabilone is a synthetic endocannabinoid and CB1 agonist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Suicidal Ideation and Behavior as assessed by an abbreviated version of the Columbia-Suicide Severity Rating Scale (CSSRS) | 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. | baseline, day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | 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. | baseline, day 3 |
| Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | 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. | baseline, day 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Machado-Vieira, MD, PhD, MSc | UTHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harris County Psychiatric Center (HCPC) | Houston | Texas | 77021 | United States |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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| Placebo | Drug | Inactive placebo comparator |
|
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. |
| baseline, day 3 |
| Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) | 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. | baseline, day 3 |