Clinical trial NCT04294654: Vortioxetine in Patients With Depression and Early Dementia
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Dementia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2020-03-04
Enrollment: 82
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
timeFrame: from baseline to Week 12
Secondary outcomes:
measure: Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score
timeFrame: from baseline to Week 12
measure: Change in Rey Auditory Verbal Learning Test (RAVLT) score
timeFrame: from baseline to Week 12
measure: Change in Instrumental Activities of Daily Living (IADL) score
timeFrame: from baseline to Week 12
measure: Change in Clinical Global Impression - Severity (CGI-S) score
timeFrame: from baseline to Week 12
measure: Clinical Global Impression - Improvement (CGI-I) score
timeFrame: at Week 12
measure: Response defined by decrease in MADRS total score
timeFrame: At Week 12
measure: Remission defined by MADRS score
timeFrame: at Week 12
measure: Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score
timeFrame: from baseline to Week 12
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Marienthali Kliinik
city: Viersat
country: France
facility: Cabinet du Docteur Karim Boutayeb
city: Villeurbanne
country: France
facility: Centre de Recherche-Hopital Geriatrique de Charpennes
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
state: Province Of Brescia
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce
state: Umbria
city: Chieti
country: Italy
facility: Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento...
city: Rome
country: Italy
facility: Fondazione Santa Lucia IRCCS
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Poznan
country: Poland
facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa
state: Wielkopolskie
city: Bialystok
country: Poland
facility: MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
city: Bydgoszcz
country: Poland
facility: NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
city: Katowice
country: Poland
facility: CareClinic
city: Kielce
country: Poland
facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala
city: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej Mentis
city: Lublin
country: Poland
facility: Centrum Medyczne Luxmed Sp.Z O.O.
city: Pruszcz Gdanski
country: Poland
facility: Nzoz Syntonia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Valladolid
country: Spain
facility: University Clinical Hospital of Valladolid
city: Valladolid
country: Spain
facility: Hospital Río Hortega
city: Vigo
country: Spain
facility: Centro de Saude de Lavadores
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: