Major Depressive DisorderPhase 4MEMORYNCT04294654
Vortioxetine in Patients With Depression and Early Dementia
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder and Dementia, run by H. Lundbeck A/S at 24 sites in 6 countries.
Trial summary
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Major Depressive Disorder, Dementia
- What is being tested?
- Vortioxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 28 Feb 2020to 20 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -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
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Poland8 sites
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
Bialystok, 15-404
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
Bydgoszcz, 85-023
CareClinic
Katowice, 40-568
Centrum Zdrowia Psychicznego Biomed - Jan Latala
Kielce, 25-411
Niepubliczny Zaklad Opieki Psychiatrycznej Mentis
Leszno, 64-100
Centrum Medyczne Luxmed Sp.Z O.O.
Lublin, 20-109
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa
Poznan, Greater Poland Voivodeship, 60-848
Nzoz Syntonia
Pruszcz Gdański, 83-000
South Korea5 sites
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380
Chonnam National University Hospital
Gwangju, 61469
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Samsung Medical Center
Seoul, 06351
Italy4 sites
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
Brescia, Province Of Brescia, 25123
Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...
Chieti, 66100
Azienda Ospedaliera di Perugia - Policlinico Monteluce
Perugia, Umbria, 06122
Fondazione Santa Lucia IRCCS
Rome, 00179
Spain4 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
University Clinical Hospital of Valladolid
Valladolid, 47010
Hospital Río Hortega
Valladolid, 47012
Centro de Saude de Lavadores
Vigo, 36214
France2 sites
Cabinet du Docteur Karim Boutayeb
Viersat, 23170
Centre de Recherche-Hopital Geriatrique de Charpennes
Villeurbanne, 69100
About this study
Official title: 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
- Conditions
- Major Depressive Disorder, Dementia
- Being tested
- Vortioxetine
- Medical subject headings
- Depressive Disorder, Major, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | 5 - 20 mg/day tablets Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to Week 12
Secondary outcomes (8)
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)."
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: at Week 12
Response defined by decrease in MADRS total score
Response is defined as a 50% decrease from baseline in MADRS total score
Measured: At Week 12
Remission defined by MADRS score
Remission is defined as MADRS ≤10
Measured: 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.
Measured: from baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start28 Feb 2020
- Primary completion6 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294654
- Sponsor's protocol ID
- 18315A
- Acronym
- MEMORY
- Status last verified
- Aug 2022
- First submitted
- 2 Mar 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37315590
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia
- ClinicalTrials.gov ID
- NCT04294654
- Acronym / sponsor ID
- MEMORY / 18315A
- Conditions
- Major Depressive Disorder, Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: Vortioxetine5 - 20 mg/day tablets |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineVortioxetine 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. | Drug | Vortioxetine |
Primary outcome
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
Time frame: from baseline to Week 12
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.
8 secondary outcomes
Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score
Time frame: from baseline to Week 12
Change in Rey Auditory Verbal Learning Test (RAVLT) score
Time frame: from baseline to Week 12
Change in Instrumental Activities of Daily Living (IADL) score
Time frame: from baseline to Week 12
Change in Clinical Global Impression - Severity (CGI-S) score
Time frame: from baseline to Week 12
Clinical Global Impression - Improvement (CGI-I) score
Time frame: at Week 12
Response defined by decrease in MADRS total score
Time frame: At Week 12
Remission defined by MADRS score
Time frame: at Week 12
Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score
Time frame: from baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 37315590Christensen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder and Dementia, run by H. Lundbeck A/S at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland, South Korea, Italy, Spain, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score (time frame: from baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.