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Serotonin Modulator

Vortioxetine for Frontotemporal Dementia

Phase 2
Waitlist Available
Led By Christopher Morrow, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or Female aged 45 and above
Presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
Must not have
No contraindications to Vortioxetine treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if vortioxetine can help improve mood and cognitive symptoms in patients with early-stage behavioral variant Frontotemporal Dementia (bvFTD). Researchers want to find out

Who is the study for?
This trial is for individuals with early-stage behavioral variant Frontotemporal Dementia (bvFTD) who experience mood symptoms. Participants must undergo clinical assessments, laboratory tests, brain imaging, and cognitive testing before and after a 12-week treatment period.
What is being tested?
The study is testing whether vortioxetine can improve mood and cognitive functions in bvFTD patients. It involves initial and follow-up brain scans (MRI & FDG PET) as well as memory and problem-solving tests to measure changes after the treatment.
What are the potential side effects?
Possible side effects of vortioxetine may include nausea, headaches, dry mouth, dizziness, sexual dysfunction, constipation or diarrhea. These are not guaranteed but are some common reactions observed in other contexts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 45 years old or older.
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I experience depression, anxiety, irritability, or agitation.
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I am not taking any medications for mental health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can safely take Vortioxetine without health risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)
Secondary study objectives
Change in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS).
Other study objectives
Change in performance on the Trail Making Test (TST).

Side effects data

From 2019 Phase 4 trial • 1106 Patients • NCT02371980
26%
Nausea
8%
Headache
5%
Nasopharyngitis
5%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label: Vortioxetine 10 mg
Double-blind: Placebo
Double-blind: Vortioxetine 5 mg
Double-blind: Vortioxetine 10 mg
Double-blind: Vortioxetine 20 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient Treatment Arm (Vortioxetine)Experimental Treatment1 Intervention
Individuals with bvFTD and mood symptoms receiving the study drug, vortioxetine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vortioxetine
2015
Completed Phase 4
~8030

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,874,679 Total Patients Enrolled
11 Trials studying Frontotemporal Dementia
860 Patients Enrolled for Frontotemporal Dementia
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,492 Total Patients Enrolled
27 Trials studying Frontotemporal Dementia
17,919 Patients Enrolled for Frontotemporal Dementia
Christopher Morrow, MDPrincipal InvestigatorJohns Hopkins University
~33 spots leftby May 2029
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