ClinicalTrials.gg
CompletedNCT03485274Updated Jul 5, 2023

Substance Misuse To Psychiatric Disorders for Cannabis

A Phase 2/3 interventional study of Vortioxetine and Treatment as Usual in Cannabis Use Disorder, Depressive State and Anxiety State, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by The University of Hong Kong · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2023, 3 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 2/3
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies testing vortioxetine in Depression — 3 open to participants now, 3 under way, none of them phase 3. Vortioxetine · Depression.

Enrollment
23rd of 30
37 · median 223
Started
2018
the only one that year
Phase 2/3
2 of 30
none open now
Registered
22nd of 30
by date

Among the 30 studies testing vortioxetine in Depression, this one is the 23rd largest by enrollment, is the only one that started in 2018, is one of 2 in phase 2/3, and was the 22nd registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

3 of the 30 studies testing vortioxetine in Depression are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

About vortioxetine

Vortioxetine: first FDA approval 2013 (TRINTELLIX), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 16 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies testing vortioxetine in Depression, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Cannabis Use Disorder
  • Depressive State
  • Anxiety State
  • Depression
  • Anxiety Disorders
  • Pharmacotherapy

Keywords

  • Cannabis
  • depression
  • anxiety
  • medication
04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age \<16 years old
  • Unable to read English or Chinese
  • Unable to give
  • Had been diagnosed to have Intellectual Disabilities () 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 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 ≥500ms and/or known unstable or untreated cardiology disease
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Vortioxetine Arm

    Oral: 5-20mg daily

    Drug: Vortioxetine

  • Active comparator
    Treatment as Usual

    Any medication or Rx other than vortixoetine

    Other: Treatment as Usual

Interventions

  • oral medication taken once daily

  • OtherTreatment as Usual

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

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. prevalence of Cannabis induced mood disorder

    The prevalence of the cannabis induced disorder in both arms

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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

    Time frame: 6 months

  4. Change in cognitive outcome

    To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms

    Time frame: 6 months

07

Study locations

1 site
  • Queen Mary Hospital
    Hong Kong, 000000, Hong Kong
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Feb 2023, 55 months.

Of 30 non-industry phase 2/3 interventional studies under Depression, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 56. This study's 55 months is above that.

Counting every sponsor, half of 32 studies reached it within 40 months; a quarter within 27 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2018
First posted
Apr 2, 2018
StartActual
Jul 25, 2018
Primary completionActual
Feb 28, 2023
CompletionActual
Apr 30, 2023
Last update
Jul 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03485274
Collaborators
Queen Mary Hospital, Hong Kong
Responsible party
Dr. Albert Kar-Kin Chung (Clinical Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Apr 2, 2018
Start date
Jul 25, 2018
Primary completion
Feb 28, 2023
Completion
Apr 30, 2023
Last update
Jul 5, 2023

Study contacts

Albert KK Chung, MBBS(HK)
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vortioxetine

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