Depression Clinical Trial
Official title:
Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study
Verified date | July 2023 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | April 30, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Queen Mary Hospital, Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in severity of Cannabis Use Disorder (CUD) | Change in severity of the cannabis use disorder for the 2 arms as defined by DSM-5 | 6 months | |
Secondary | prevalence of Cannabis induced mood disorder | The prevalence of the cannabis induced disorder in both arms | 6 months | |
Secondary | Change in Hamilton anxiety (HAM-A) rating scale | 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 | 6 months | |
Secondary | Change in Hamilton depression (HAM-D) rating scale | 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 | 6 months | |
Secondary | Change in cognitive outcome | To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms | 6 months |
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