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Hoarding DisorderPhase 3NCT04035850

Vortioxetine for the Treatment of Hoarding Disorder

A Phase 3 study testing Vortioxetine Tablets in people with Hoarding Disorder, run by Noam Soreni at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The present study is a single-group open-label investigation of the potential efficacy of Vortioxetine for treatment of 30 adult volunteers with Hoarding Disorder (HD) (flexible-dose study, with a target dose range 5-25mg). Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Hoarding Disorder
What is being tested?
Vortioxetine Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
1 Aug 2019to 1 Aug 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a principal DSM-5 diagnosis of HD
  • SI-R score>=40
  • age between 25-65
  • no other antidepressant use in the 4 weeks that precede the first Vortioxetine dose*
  • ability to provide written informed consent
  • Patients on non-Vortioxetine antidepressant who are willing to participate in the study and meet all other inclusion and exclusion criteria will be offered a 4-week antidepressant wash out period.

Who cannot join

  • current or past diagnosis of mania/hypo-mania, psychotic disorder or a 1st-degree relative with bipolar disorder or a psychotic disorder
  • past history of behavioural activation or suicidal ideations on antidepressant medication
  • known hypersensitivity to Vortioxetine
  • concomitant use of other antidepressants
  • current participation in CBT for HD or OCD
  • concomitant use of a MAO inhibitor
  • known hepatic insufficiency
  • pregnancy.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St Joseph Healthcare

    Hamilton, Ontario, L8N 3K7

Other trials in Canada

About this study

Official title: Vortioxetine for the Treatment of Hoarding Disorder- an Open Label Study

The present study is a single-group open-label investigation of the potential efficacy of Vortioxetine for treatment of 30 adult volunteers with Hoarding Disorder (HD) (flexible-dose study, with a target dose range 5-25mg). The proposed study will be the first Vortioxetine study in HD, and conducted at the Anxiety Treatment and Research Clinic (ATRC) Canada's largest academic anxiety clinic, a regional referral center for individuals with HD. The study requires a Letter of No Objection from Health Canada and the study will be approved by Hamilton Integrated Research Ethics Board (HiREB).

Read the detailed description

Hoarding disorder (HD) is a common and severe new diagnostic category. HD has two core dimensions: difficulty discarding items and the resultant clutter, which may preclude the use of living spaces for their intended. Other HD criteria, distress and impairment, often include unemployment, removal of children, health risks (e.g. infestations, falls, fires, etc.). The estimated prevalence of hoarding is 5.3% in adults and 2% in youth.

Existing treatments of hoarding are only partially effective. Emerging evidence supports the partial efficacy of cognitive behavioral therapy (CBT) in the treatment of HD though, paradoxically, this therapy mostly addresses the excessive attachment to possessions but not the above-identified cognitive deficits. On the other hand, the study of pharmacological treatments for hoarding is in preliminary stages and there currently are no well-validated or official guidelines for the use of psychotropic medications in HD. Given that HD is a highly prevalent and severe condition, there is an urgent need to address this gap in the literature to improve the well-being of patients with the disorder.

Emerging evidence suggests that serotonergic medications may have an important role in the treatment of HD. First, HD is highly comorbid with obsessive-compulsive disorder (OCD) and major depressive disorder (MDD), two disorders that respond well to serotonergic medications. Second, a recent meta analysis of 14 clinical trials suggested that hoarding symptoms had responded to selective serotonin reuptake inhibitor (SSRIs) (i.e., paroxetine and sertraline) and venlafaxine, a serotonin and norepinephrine reuptake inhibitor, with response rates ranging between 37%-76% of participants. Interestingly, this response rate is similar to response rates reported by meta-analyses of the treatment response of OCD to SRIs. However, those findings should be interpreted with caution given the lack of controlled studies and the diagnostic heterogeneity, the latter a result of the diagnostic ambiguity that prevailed prior to the introduction of HD in the fifth version of the Diagnostic and Statistical Manual (DSM-5).

Treatment of hoarding symptoms should ideally target the obsessional aspect of the syndrome (abnormal attachment to possessions), some or all of the identified cognitive deficits and commonly associated comorbidities. Although preoccupation with possessions, an OCD/MDD-like feature of hoarding, can arguably be addressed by the use of Serotonin reuptake inhibitors (SR) medications that are highly effective for the treatment of OCD and MDD , targeting cognitive deficits in hoarding likely requires a different approach and the use of newer generation serotonergic medications.

Vortioxetine is a novel serotonergic antidepressant with a unique pharmacodynamics profile, reported precognitive effects and proven efficacy for the treatment of MDD . Vortioxetine is a 5-HT3, 5-HT7 and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and serotonin (5-HT) transporter (SERT) inhibitor. There is preliminary evidence that Vortioxetine's unique serotonergic modulation profile may be associated with distinct mechanisms of action at the brain network level. In addition, several studies1 report that Vortioxetine is associated with improved cognitive performance in patients with MDD. These procognitve effects appear to distinguish Vortioxetine from other antidepressant agents. As such, Vortioxetine should be considered a prime candidate for medication trials in HD. To date, however, no studies of vortioxetine in HD have been published.

With this in mind the goal of the present study is to conduct a preliminary, single-group open-label investigation of the potential efficacy of Vortioxetine for treatment of 30 adult volunteers with HD (flexible-dose study, with a target dose range 5-25mg). The proposed study will be the first Vortioxetine study in HD, and conducted at the ATRC Canada's largest academic anxiety clinic, a regional referral center for individuals with HD. The study requires a letter of no objection from Health Canada and the study will be approved by Hamilton Integrated Research Ethics Board (HiREB).

Being tested
Vortioxetine Tablets
Medical subject headings
Hoarding Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vortioxetine TabletsDrug

    Also called Trintellix

    Strength 5-20 mg

Study groups in NCT04035850
Study groupRoleWhat they receive
ParticipantsExperimentalVortioxetine PO tablets, 5-20mg Daily
Receives: Drug: Vortioxetine Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Saving-inventory Revised (SI-R)

    A self report scale.23-item self-report measure comprising three subscales: difficulty discarding, clutter, and excessive acquisition .

    Items on the SI-R are scored between 0 and 4, with higher scores indicating greater hoarding severity. Total score = sum of all items Range = 0-92. A total score of >46 represents clinically significant hoarding

    Measured: 12 weeks

  2. Hoarding cognitions Inventory

    Saving cognition Inventory A self report scale that measures hoarding related cognitions.24-item self-report measure of hoarding severity.

    Items on the SI-R are scored between 1 and 7, with higher scores representing more severe hoarding symptoms. indicating Total score = sum of all items, Range = 0-168. Mean score in non clinical population - 42, SD-20; mean score in individuals with HD 95.9 , SD=31.0.

    Measured: 12 weeks

Secondary outcomes (3)
  1. Activities of daily life of hoarding (ADL-H)

    A self report scale to assess hoarding-related functional impairment

    Total score = sum all 15 items after excluding those rated "Not Applicable"; divide the summed score by the number of items given a numerical rating. This will yield an average of all applicable items. Range = 1-5, score greater than 3 suggests marked functional impairment.

    Measured: 12 weeks

  2. Cognitive changes 1

    Cambridge cognition tests:

    Cambridge Gambling Task Multitasking Test Spatial span test Stockings of Cambridge Stop Signal Task

    Measured: 12 weeks

  3. Cognitive changes 2

    Digit Symbol Substitution Test (DSST)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start1 Aug 2019 (estimated)
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion1 Aug 2021 (estimated)

Why it stopped: COVID-19 pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single group, open label study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04035850
Sponsor's protocol ID
7206
Status last verified
Jan 2024
First submitted
17 Jun 2019
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vortioxetine Tablets in people with Hoarding Disorder, run by Noam Soreni at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Saving-inventory Revised (SI-R) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.

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