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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Experimental | 5 - 20 mg/day tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)." |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marienthali Kliinik | Tallinn | 11315 | Estonia | |||
| Cabinet du Docteur Karim Boutayeb |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37315590 | Derived | 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. |
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| 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. | 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 | 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). | 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). | at Week 12 |
| Response defined by decrease in MADRS total score | Response is defined as a 50% decrease from baseline in MADRS total score | At Week 12 |
| Remission defined by MADRS score | Remission is defined as MADRS ≤10 | 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. | from baseline to Week 12 |
| Viersat |
| 23170 |
| France |
| Centre de Recherche-Hopital Geriatrique de Charpennes | Villeurbanne | 69100 | France |
| Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia | Brescia | Province Of Brescia | 25123 | Italy |
| Azienda Ospedaliera di Perugia - Policlinico Monteluce | Perugia | Umbria | 06122 | Italy |
| Fondazione Universitaria G.D'Annunzio Ce.S.I. Centro Ricerca (Centro Scienze del l'Invecchiamento... | Chieti | 66100 | Italy |
| Fondazione Santa Lucia IRCCS | Rome | 00179 | Italy |
| Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Spolka Komandytowa | Poznan | Greater Poland Voivodeship | 60-848 | Poland |
| MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk | Bialystok | 15-404 | Poland |
| NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. | Bydgoszcz | 85-023 | Poland |
| CareClinic | Katowice | 40-568 | Poland |
| Centrum Zdrowia Psychicznego Biomed - Jan Latala | Kielce | 25-411 | Poland |
| Niepubliczny Zaklad Opieki Psychiatrycznej Mentis | Leszno | 64-100 | Poland |
| Centrum Medyczne Luxmed Sp.Z O.O. | Lublin | 20-109 | Poland |
| Nzoz Syntonia | Pruszcz Gdański | 83-000 | Poland |
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | 10380 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | 01830 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| University Clinical Hospital of Valladolid | Valladolid | 47010 | Spain |
| Hospital Río Hortega | Valladolid | 47012 | Spain |
| Centro de Saude de Lavadores | Vigo | 36214 | Spain |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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