Vortioxetine in Patients With Depression and Early Dementia

Major Depressive Disorder Clinical Trial

— MEMORY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294654
• Other study ID #: 18315A
• Status: Completed
• Phase: Phase 4
• Start date: February 28, 2020
• Est. completion date: July 20, 2022

Study information

• Verified date: August 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 20, 2022
• Est. primary completion date: July 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Estonia	Marienthali Kliinik	Tallinn
France	Cabinet du Docteur Karim Boutayeb	Viersat
France	Centre de Recherche-Hopital Geriatrique de Charpennes	Villeurbanne
Italy	Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia	Brescia	Province Of Brescia
Italy	Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...	Chieti
Italy	Azienda Ospedaliera di Perugia - Policlinico Monteluce	Perugia	Umbria
Italy	Fondazione Santa Lucia IRCCS	Rome
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Poland	MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk	Bialystok
Poland	NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.	Bydgoszcz
Poland	CareClinic	Katowice
Poland	Centrum Zdrowia Psychicznego Biomed - Jan Latala	Kielce
Poland	Niepubliczny Zaklad Opieki Psychiatrycznej Mentis	Leszno
Poland	Centrum Medyczne Luxmed Sp.Z O.O.	Lublin
Poland	Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa	Poznan	Wielkopolskie
Poland	Nzoz Syntonia	Pruszcz Gdanski
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Río Hortega	Valladolid
Spain	University Clinical Hospital of Valladolid	Valladolid
Spain	Centro de Saude de Lavadores	Vigo

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	ICON plc

Countries where clinical trial is conducted

Estonia,  France,  Italy,  Korea, Republic of,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Response defined by decrease in MADRS total score	Response is defined as a 50% decrease from baseline in MADRS total score	At Week 12
Secondary	Remission defined by MADRS score	Remission is defined as MADRS =10	at Week 12
Secondary	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