Vortioxetine in Patients With Depression and Early Dementia (MEMORY)

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

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

Study Overview

• Status: Completed
• Conditions: Dementia; Major Depressive Disorder
• Intervention / Treatment: Drug: Vortioxetine

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 11315
    • Marienthali Kliinik
• France
  • Viersat, France, 23170
    • Cabinet du Docteur Karim Boutayeb
  • Villeurbanne, France, 69100
    • Centre de Recherche-Hopital Geriatrique de Charpennes
• Italy
  • Chieti, Italy, 66100
    • Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...
  • Rome, Italy, 00179
    • Fondazione Santa Lucia IRCCS
  • Province Of Brescia
    • Brescia, Province Of Brescia, Italy, 25123
      • Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia
  • Umbria
    • Perugia, Umbria, Italy, 06122
      • Azienda Ospedaliera di Perugia - Policlinico Monteluce
• Korea, Republic of
  • Gwangju-si, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of, 01830
    • Nowon Eulji Medical Center, Eulji University
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
      • Inje University Ilsan Paik Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
• Poland
  • Bialystok, Poland, 15-404
    • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
  • Bydgoszcz, Poland, 85-023
    • NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
  • Katowice, Poland, 40-568
    • CareClinic
  • Kielce, Poland, 25-411
    • Centrum Zdrowia Psychicznego Biomed - Jan Latala
  • Leszno, Poland, 64-100
    • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
  • Lublin, Poland, 20-109
    • Centrum Medyczne Luxmed Sp.z o.o.
  • Pruszcz Gdanski, Poland, 83-000
    • NZOZ Syntonia
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-848
      • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Valladolid, Spain, 47012
    • Hospital Rio Hortega
  • Valladolid, Spain, 47010
    • University Clinical Hospital of Valladolid
  • Vigo, Spain, 36214
    • Centro de Saude de Lavadores

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Other in- and exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vortioxetine; 5 - 20 mg/day tablets	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score	Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)."	from baseline to Week 12
Change in Rey Auditory Verbal Learning Test (RAVLT) score	Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.	from baseline to Week 12
Change in Instrumental Activities of Daily Living (IADL) score	The Instrumental Activities of Daily Living (IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and are assessed by informant interview. The scores for IADL (0-14) is the outcome, with higher scores indicating lesser ability to carry out daily living tasks	from baseline to Week 12
Change in Clinical Global Impression - Severity (CGI-S) score	The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).	from baseline to Week 12
Clinical Global Impression - Improvement (CGI-I) score	The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	at Week 12
Response defined by decrease in MADRS total score	Response is defined as a 50% decrease from baseline in MADRS total score	At Week 12
Remission defined by MADRS score	Remission is defined as MADRS ≤10	at Week 12
Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score	The BASQID30 is a clinician rating scale designed to assess subjective quality of life (QoL) in patients with dementia. The BASQID contains 14 core questions, which are scored from 0 to 4, with 4 indicating a better QoL.	from baseline to Week 12

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Collaborators: ICON plc

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Neurocognitive Disorders; Depression; Depressive Disorder; Dementia; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 18315A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No