Vortioxetine for the Treatment of Hoarding Disorder

NCT04035850 | Withdrawn Phase 3 DMC

• 1 other identifier: 7206
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hoarding Disorder

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  12 weeks

Secondary Outcomes (3)

• Activities of daily life of hoarding (ADL-H)

  12 weeks

• Cognitive changes 1

  12 weeks

• Cognitive changes 2

  12 weeks

Study Arms (1)

Participants

EXPERIMENTAL

Vortioxetine PO tablets, 5-20mg Daily

Drug: Vortioxetine Tablets

Interventions

Vortioxetine Tablets DRUG

Strength 5-20 mg

Also known as: Trintellix

Participants

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noam Soreni: lead

Study Sites (1)

St Joseph Healthcare

Hamilton, Ontario, L8N 3K7, Canada

Location

MeSH Terms

Conditions

Hoarding Disorder

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Noam Soreni, MD

  McMaster University, St. Joseph's Healthcare, hamilton, Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Principal investigator

Model Details: Single group, open label study

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)