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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04294654
Other study ID # 18315A
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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