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Vortioxetine in Patients With Depression and Early Dementia (MEMORY)

Primary Purpose

Major Depressive Disorder, Dementia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vortioxetine
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Other in- and exclusion criteria may apply

Sites / Locations

  • Marienthali Kliinik
  • Cabinet du Docteur Karim Boutayeb
  • Centre de Recherche-Hopital Geriatrique de Charpennes
  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
  • Azienda Ospedaliera di Perugia - Policlinico Monteluce
  • Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...
  • Fondazione Santa Lucia IRCCS
  • Inje University Ilsan Paik Hospital
  • Seoul National University Bundang Hospital
  • Chonnam National University Hospital
  • Nowon Eulji Medical Center, Eulji University
  • Samsung Medical Center
  • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa
  • MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
  • NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
  • CareClinic
  • Centrum Zdrowia Psychicznego Biomed - Jan Latala
  • Niepubliczny Zaklad Opieki Psychiatrycznej Mentis
  • Centrum Medyczne Luxmed Sp.Z O.O.
  • Nzoz Syntonia
  • Hospital Clinic i Provincial de Barcelona
  • University Clinical Hospital of Valladolid
  • Hospital Río Hortega
  • Centro de Saude de Lavadores

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vortioxetine

Arm Description

5 - 20 mg/day tablets

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)."
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.
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
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).
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).
Response defined by decrease in MADRS total score
Response is defined as a 50% decrease from baseline in MADRS total score
Remission defined by MADRS score
Remission is defined as MADRS ≤10
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.

Full Information

First Posted
March 2, 2020
Last Updated
August 5, 2022
Sponsor
H. Lundbeck A/S
Collaborators
ICON plc
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1. Study Identification

Unique Protocol Identification Number
NCT04294654
Brief Title
Vortioxetine in Patients With Depression and Early Dementia
Acronym
MEMORY
Official Title
Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
ICON plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Experimental
Arm Description
5 - 20 mg/day tablets
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
Description
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.
Time Frame
from baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score
Description
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)."
Time Frame
from baseline to Week 12
Title
Change in Rey Auditory Verbal Learning Test (RAVLT) score
Description
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.
Time Frame
from baseline to Week 12
Title
Change in Instrumental Activities of Daily Living (IADL) score
Description
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
Time Frame
from baseline to Week 12
Title
Change in Clinical Global Impression - Severity (CGI-S) score
Description
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).
Time Frame
from baseline to Week 12
Title
Clinical Global Impression - Improvement (CGI-I) score
Description
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).
Time Frame
at Week 12
Title
Response defined by decrease in MADRS total score
Description
Response is defined as a 50% decrease from baseline in MADRS total score
Time Frame
At Week 12
Title
Remission defined by MADRS score
Description
Remission is defined as MADRS ≤10
Time Frame
at Week 12
Title
Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score
Description
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.
Time Frame
from baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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. Other in- and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Marienthali Kliinik
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Facility Name
Cabinet du Docteur Karim Boutayeb
City
Viersat
ZIP/Postal Code
23170
Country
France
Facility Name
Centre de Recherche-Hopital Geriatrique de Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
City
Brescia
State/Province
Province Of Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia - Policlinico Monteluce
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06122
Country
Italy
Facility Name
Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Fondazione Santa Lucia IRCCS
City
Rome
ZIP/Postal Code
00179
Country
Italy
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju-si
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical Center, Eulji University
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-848
Country
Poland
Facility Name
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-023
Country
Poland
Facility Name
CareClinic
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Centrum Zdrowia Psychicznego Biomed - Jan Latala
City
Kielce
ZIP/Postal Code
25-411
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Psychiatrycznej Mentis
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
Centrum Medyczne Luxmed Sp.Z O.O.
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Facility Name
Nzoz Syntonia
City
Pruszcz Gdanski
ZIP/Postal Code
83-000
Country
Poland
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
University Clinical Hospital of Valladolid
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Facility Name
Hospital Río Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Centro de Saude de Lavadores
City
Vigo
ZIP/Postal Code
36214
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vortioxetine in Patients With Depression and Early Dementia

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