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Vortioxetine in Patients With Depression and Early Dementia | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Vortioxetine in Patients With Depression and Early Dementia

Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia

NCT04294654•H. Lundbeck A/S

View on ClinicalTrials.gov

Summary

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient has a primary diagnosis of recurrent Major Depressive Disorder (MDD) with onset before age of 55, diagnosed according to DSM-5®
•The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
•The patient has had the current MDE for \<6 months.
•The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Baseline Visit.
•The diagnosis of onset of dementia has occurred at least 6 months prior to screening and after already being diagnosed with MDD. The diagnosis of dementia must be documented in patient's medical records. When deemed necessary per investigator judgement of patient clinical status and early dementia, the patient must be accompanied by a caregiver to study visits.
•Patients with dementia associated with vitamin B12 or folate deficiency should not be enrolled.
•Patients with or without treatment for dementia can be enrolled. For patients on treatment for dementia, there must be no change in treatment during the study and patients must be on stable dose for at least 3 months prior to the Screening Visit.
•The patient has Mini Mental State Examination (MMSE) total score 20-24, inclusive.

Exclusion Criteria

•The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.

Locations (24)

Marienthali Kliinik

Tallinn, Estonia

Cabinet du Docteur Karim Boutayeb

Viersat, France

Centre de Recherche-Hopital Geriatrique de Charpennes

Villeurbanne, France

Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

Brescia, Province Of Brescia, Italy

Azienda Ospedaliera di Perugia - Policlinico Monteluce

Perugia, Umbria, Italy

Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...

Chieti, Italy

Fondazione Santa Lucia IRCCS

Rome, Italy

Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa

Poznan, Greater Poland Voivodeship, Poland

MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, Poland

NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.

Bydgoszcz, Poland

Key Dates

Start Date

February 28, 2020

Primary Completion Date

July 6, 2022

Completion Date

July 20, 2022

Last Updated

August 8, 2022

Enrollment

ACTUAL participants

Conditions

Major Depressive DisorderDementia

Interventions

Vortioxetine

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vortioxetine in Patients With Depression and Early Dementia

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment