Vortioxetine for the Treatment of Hoarding Disorder

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noam Soreni
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

1. a principal DSM-5 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 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.

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 hypersensitivity 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.