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.
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.
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).
- Conditions
- Hoarding Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Vortioxetine 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.
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
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)
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
Cognitive changes 1
Cambridge cognition tests:
Cambridge Gambling Task Multitasking Test Spatial span test Stockings of Cambridge Stop Signal Task
Measured: 12 weeks
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.
- First posted29 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Noam Soreni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noam Soreni, St. Joseph's Healthcare Hamilton
- Investigators
- Noam Soreni, MD, Principal investigator, McMaster University, St. Joseph's Healthcare, hamilton, Ontario
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vortioxetine for the Treatment of Hoarding Disorder- an Open Label Study
- ClinicalTrials.gov ID
- NCT04035850
- Acronym / sponsor ID
- 7206
- Conditions
- Hoarding Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Noam SoreniUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open label study
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Drug: Vortioxetine TabletsVortioxetine PO tablets, 5-20mg Daily |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine TabletsAlso: TrintellixStrength 5-20 mg | Drug | Participants |
Primary outcome
Saving-inventory Revised (SI-R)
Time frame: 12 weeks
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
Hoarding cognitions Inventory
Time frame: 12 weeks
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.
3 secondary outcomes
Activities of daily life of hoarding (ADL-H)
Time frame: 12 weeks
Cognitive changes 1
Time frame: 12 weeks
Cognitive changes 2
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noam Soreni, MD principal investigator
McMaster University, St. Joseph's Healthcare, hamilton, Ontario
1 site in 1 country: see every site and its status.
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.