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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03485274
Other study ID # SToP-C
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 25, 2018
Est. completion date April 30, 2023

Study information

Verified date July 2023
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Vortioxetine
oral medication taken once daily
Other:
Treatment as Usual
Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine

Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
The University of Hong Kong Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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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