MEMORY: Vortioxetine in Patients With Depression and Early Dementia

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT04294654

Collaborator

ICON plc (Industry)

Enrollment

Locations

Arm

28.7

Actual Duration (Months)

3.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Dementia	Drug: Vortioxetine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 28, 2020

Actual Primary Completion Date :

Jul 6, 2022

Actual Study Completion Date :

Jul 20, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score [from baseline to Week 12]
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 [from baseline to Week 12]
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 [from baseline to Week 12]
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 [from baseline to Week 12]
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 [at Week 12]
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 [At Week 12]
Response is defined as a 50% decrease from baseline in MADRS total score
Remission defined by MADRS score [at Week 12]
Remission is defined as MADRS ≤10
Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score [from baseline to Week 12]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

H. Lundbeck A/S
ICON plc

Investigators

Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT04294654

Other Study ID Numbers:

18315A

First Posted:

Mar 4, 2020

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Depressive Disorder

Depression

Depressive Disorder, Major

Vortioxetine

Study Results

No Results Posted as of Aug 8, 2022