Anxiety Disorders, Anxiety State, Cannabis Use Disorder, Depression, Depressive State, Pharmacotherapy
Conditions
Keywords
Cannabis, depression, anxiety, medication
Brief summary
With the recent availability of vortioxetine, and the surging phenomenon of cannabis misuses amongst young abusers, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with cannabis use disorders with depressive or anxiety symptoms, to develop into a more chronic disabling dependence or co-morbid state.
Interventions
DRUGVortioxetine
oral medication taken once daily
OTHERTreatment as Usual
Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine
Sponsors
Queen Mary Hospital, Hong Kong
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
treatment in each intervention arms is masked to the outcome assessor
Intervention model description
prospective randomised single-blinded
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms
Exclusion criteria
* Age \<16 years old * Unable to read English or Chinese * Unable to give informed consent * Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation * Had history of primary psychotic episode * Had been diagnosed to have substance-induced mood disorder, other than cannabis * Had been diagnosed to have mood disorders or anxiety disorders * Had been taking maintenance therapeutic dose of antidepressant continuously \>= 6 months AND with depressive symptom or anxiety symptom being in remission * Had known hypersensitivity to vortioxetine * Had known history of serotonin syndrome * Pregnant * Mother currently breast-feeding * Currently taking warfarin and/or having poorly controlled bleeding disorder * Had history of prolonged QTc ≥500ms and/or known unstable or untreated cardiology disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in severity of Cannabis Use Disorder (CUD) | 6 months | Change in severity of the cannabis use disorder for the 2 arms as defined by DSM-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of Cannabis induced mood disorder | 6 months | The prevalence of the cannabis induced disorder in both arms |
| Change in Hamilton anxiety (HAM-A) rating scale | 6 months | To assess the change of anxiety severity of the two treatment arms using HAM-A for both treatment arms with cut-off of defining anxiety \>=14 |
| Change in Hamilton depression (HAM-D) rating scale | 6 months | To assess the change of depression severity of the two treatment arms using HAM-D for both treatment arms with cut-off of defining depression \>=8 |
| Change in cognitive outcome | 6 months | To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms |
Countries
Hong Kong
Outcome results
None listed