Vortioxetine in Patients With Depression and Early Dementia

NCT ID: NCT04294654

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2022-07-20

Brief Summary

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

Conditions

Major Depressive Disorder; Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vortioxetine

5 - 20 mg/day tablets

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Vortioxetine 5, 10 and 20 mg/day, tablets, orally Patients will receive 5 mg vortioxetine once daily for one week. At visit 3, the dose will be increased to 10 mg/day for all patients. Thereafter the dose may be adjusted to 5, 10 or 20 mg/day.

Interventions

Vortioxetine

Vortioxetine 5, 10 and 20 mg/day, tablets, orally Patients will receive 5 mg vortioxetine once daily for one week. At visit 3, the dose will be increased to 10 mg/day for all patients. Thereafter the dose may be adjusted to 5, 10 or 20 mg/day.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON plc

INDUSTRY

Sponsor Role: collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

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

CareClinic

Katowice, , Poland

Centrum Zdrowia Psychicznego Biomed - Jan Latala

Kielce, , Poland

Niepubliczny Zaklad Opieki Psychiatrycznej Mentis

Leszno, , Poland

Centrum Medyczne Luxmed Sp.Z O.O.

Lublin, , Poland

Nzoz Syntonia

Pruszcz Gdański, , Poland

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

University Clinical Hospital of Valladolid

Valladolid, , Spain

Hospital Río Hortega

Valladolid, , Spain

Centro de Saude de Lavadores

Vigo, , Spain

Countries

Estonia; France; Italy; Poland; South Korea; Spain

References

Christensen MC, Schmidt SN, Grande I. Effectiveness of vortioxetine in patients with major depressive disorder and early-stage dementia: The MEMORY study. J Affect Disord. 2023 Oct 1;338:423-431. doi: 10.1016/j.jad.2023.06.024. Epub 2023 Jun 12.

Reference Type: DERIVED

PMID: 37315590 (View on PubMed)

Other Identifiers

18315A

Identifier Type: -

Identifier Source: org_study_id