ClinicalTrials.gg
WithdrawnNCT04035850Updated Feb 2, 2024

Vortioxetine for the Treatment of Hoarding Disorder

A Phase 3 interventional study of Vortioxetine Tablets in Hoarding Disorder, sponsored by Noam Soreni. Withdrawn at 1 site in Canada. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Noam Soreni · Phase 3, Interventional, and Treatment

Why this study was withdrawn
COVID-19 pandemic
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
25 Years to 65 Years
Sex
All
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Study 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). 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).

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Conditions studied

  • Hoarding Disorder

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03

In context

Hoarding Disorder

32 studies on the registry are indexed under Hoarding Disorder; 5 are open to participants now.

Browse Hoarding Disorder studies →

Lead sponsor

This is the only study on the registry with Noam Soreni as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 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

  1. a principal diagnosis of HD
  2. SI-R score>=40
  3. age between 25-65
  4. no other antidepressant use in the 4 weeks that precede the first Vortioxetine dose*
  5. ability to provide written

    • 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.

Exclusion criteria

Exclusion Criteria:

  1. current or past diagnosis of mania/hypo-mania, psychotic disorder or a 1st-degree relative with bipolar disorder or a psychotic disorder
  2. past history of behavioural activation or suicidal ideations on antidepressant medication
  3. known to Vortioxetine
  4. concomitant use of other antidepressants
  5. current participation in CBT for HD or OCD
  6. concomitant use of a MAO inhibitor
  7. known hepatic insufficiency
  8. pregnancy.
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Participants

    Vortioxetine PO tablets, 5-20mg Daily

    Drug: Vortioxetine Tablets

Interventions

06

What researchers measure

Primary outcomes

  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

    Time frame: 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.

    Time frame: 12 weeks

Secondary outcomes

  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.

    Time frame: 12 weeks

  2. Cognitive changes 1

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

    Time frame: 12 weeks

  3. Cognitive changes 2

    Digit Symbol Substitution Test (DSST)

    Time frame: 12 weeks

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Study locations

1 site
  • St Joseph Healthcare
    Hamilton, Ontario L8N 3K7, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04035850
Lead sponsor
Noam Soreni
Responsible party
Noam Soreni (Associate Professor, Principal investigator, St. Joseph's Healthcare Hamilton) — Sponsor-investigator
First posted
Jul 29, 2019
Start date
Aug 1, 2019 (estimated)
Primary completion
Aug 1, 2021 (estimated)
Completion
Aug 1, 2021 (estimated)
Last update
Feb 2, 2024

Study contacts

Noam Soreni, MD
principal investigator · McMaster University, St. Joseph's Healthcare, hamilton, Ontario

Oversight

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

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This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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