Vortioxetine in Patients With Depression and Early Dementia

NCT04294654 | Completed Phase 4

• 1 other identifier: 18315A
• Study Type: interventional
• Target: 82
• Locations: 5 countries
• Sites: 23

Brief Summary

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

Conditions

Major Depressive Disorder; Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score

  The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.

  from baseline to Week 12

Secondary Outcomes (8)

• Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score

  from baseline to Week 12

• Change in Rey Auditory Verbal Learning Test (RAVLT) score

  from baseline to Week 12

• Change in Instrumental Activities of Daily Living (IADL) score

  from baseline to Week 12

• Change in Clinical Global Impression - Severity (CGI-S) score

  from baseline to Week 12

• Clinical Global Impression - Improvement (CGI-I) score

  at Week 12

Study Arms (1)

Vortioxetine

EXPERIMENTAL

5 - 20 mg/day tablets

Drug: Vortioxetine

Interventions

Vortioxetine 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.

Vortioxetine

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• ICON plc: collaborator

Study Sites (24)

Marienthali Kliinik

Tallinn, 11315, Estonia

Location

Cabinet du Docteur Karim Boutayeb

Viersat, 23170, France

Location

Centre de Recherche-Hopital Geriatrique de Charpennes

Villeurbanne, 69100, France

Location

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

Brescia, Province Of Brescia, 25123, Italy

Location

Azienda Ospedaliera di Perugia - Policlinico Monteluce

Perugia, Umbria, 06122, Italy

Location

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

Chieti, 66100, Italy

Location

Fondazione Santa Lucia IRCCS

Rome, 00179, Italy

Location

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

Poznan, Greater Poland Voivodeship, 60-848, Poland

Location

MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, 15-404, Poland

Location

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

Bydgoszcz, 85-023, Poland

Location

CareClinic

Katowice, 40-568, Poland

Location

Centrum Zdrowia Psychicznego Biomed - Jan Latala

Kielce, 25-411, Poland

Location

Niepubliczny Zaklad Opieki Psychiatrycznej Mentis

Leszno, 64-100, Poland

Location

Centrum Medyczne Luxmed Sp.Z O.O.

Lublin, 20-109, Poland

Location

Nzoz Syntonia

Pruszcz Gdański, 83-000, Poland

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

University Clinical Hospital of Valladolid

Valladolid, 47010, Spain

Location

Hospital Río Hortega

Valladolid, 47012, Spain

Location

Centro de Saude de Lavadores

Vigo, 36214, Spain

Location

Related Publications (1)

• 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.

  PMID: 37315590 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Dementia

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: February 28, 2020
• Primary Completion: July 6, 2022
• Study Completion: July 20, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

PL (8); FR (2); ES (4); KR (5); IT (4)