NCT03485274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 25, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

4.6 years

First QC Date

March 14, 2018

Last Update Submit

July 2, 2023

Conditions

Cannabis Use DisorderDepressive StateAnxiety StateDepressionAnxiety DisordersPharmacotherapy

Keywords

Cannabisdepressionanxietymedication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • prevalence of Cannabis induced mood disorder

    6 months

  • Change in Hamilton anxiety (HAM-A) rating scale

    6 months

  • Change in Hamilton depression (HAM-D) rating scale

    6 months

  • Change in cognitive outcome

    6 months

Study Arms (2)

Vortioxetine Arm

ACTIVE COMPARATOR

Oral: 5-20mg daily

Drug: Vortioxetine

Treatment as Usual

ACTIVE COMPARATOR

Any medication or Rx other than vortixoetine

Other: Treatment as Usual

Interventions

VortioxetineDRUG

oral medication taken once daily

Vortioxetine Arm
Treatment as UsualOTHER

Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine

Treatment as Usual

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersMarijuana Abuse

Interventions

VortioxetineTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Albert KK Chung, MBBS(HK)

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
treatment in each intervention arms is masked to the outcome assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomised single-blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 14, 2018

First Posted

April 2, 2018

Study Start

July 25, 2018

Primary Completion

February 28, 2023

Study Completion

April 30, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

HK(1)