Study Synopses

Study Synopses

Lundbeck provides open access to clinical trial result summaries (synopses) from Lundbeck-sponsored phase II-IV trials completed after January 1, 2014, following market authorization in US or EU.
Product (compound) Brief title Year
Official study title Lundbeck study identifier Other identifier(s): ClinicalTrials.gov, EudraCT
Abilify Maintena® (aripiprazole) Aripiprazole once-monthly versus paliperidone palmitate in adult patients with schizophrenia 2015 A 28-week, randomised, open-label study evaluating the effectiveness of aripiprazole once-monthly versus paliperidone palmitate in adult patients with schizophrenia 14724A

NCT01795547

2012-002785-12

Abilify Maintena® (aripiprazole) Aripiprazole once-monthly in patients with schizophrenia 2015 Interventional, open-label, flexible-dose extension study of aripiprazole once-monthly in patients with schizophrenia 14724B

NCT01959035

2012-003239-47

Azilect®
(rasagiline)
Rasagiline in cognitive-impairment related depression: Azilect in cognitive-impairment related depression (ACCORDO) 2014 A randomised, double-blind, placebo-controlled study to evaluate if rasagiline can improve depressive symptoms and cognitive function in non-demented, idiopathic Parkinson's disease patients. ACCORDO Study (Azilect® in cognitive-impairment related depression) 12962A

NCT01055379

2009-011144-19

Azilect®
(rasagiline)
Rasagiline in early Parkinson's disease patients not treated with levodopa in China 2014 Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of rasagiline in early Parkinson's disease patients not treated with levodopa in China 13485A

NCT01556165

EudraCT N/A

Brintellix® (vortioxetine) Vortioxetine in Patients With Depression and Early Dementia (MEMORY) 2022 Interventional, open-label study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder and early dementia 18315A

NCT04294654

2019-001326-10

Brintellix® (vortioxetine) Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age 2022 Long-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 18 years of age 12712A NCT02871297
2008-005356-25
Brintellix® (vortioxetine) Vortioxetine to Prevent Return of Symptoms in Children With Depression 2022 A double-blind, randomized, placebo-controlled, multicentre, relapse-prevention study of vortioxetine in paediatric patients aged 7 to 11 years with Major Depressive Disorder 13546A NCT05014919
2010-020493-42
Brintellix® (vortioxetine) Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India 2022 Open-label, flexible-dose study of vortioxetine in patients with Major Depressive Disorder in India 17775A NCT04288895
EudraCT N/A
Brintellix® (vortioxetine) Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD) 2022 Interventional, randomized, double-blind, placebocontrolled, active-reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 7 to 11 years, with Major Depressive Disorder (MDD) 12709A NCT02709655
2008-005353-38
Brintellix® (vortioxetine) Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression (VIVRE) 2022 A randomized, double-blind, parallel-group, active-controlled study evaluating the efficacy of vortioxetine versus desvenlafaxine in adult patients suffering from major depressive disorder with partial response to SSRI treatment 18498A NCT04448431
2019-002704-41
Brintellix®
(vortioxetine)
Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD) (RECONNECT) 2021 Interventional, open-label effectiveness study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder comorbid with generalized anxiety disorder 18314A

NCT04220996

2019-001325-27

Brintellix®
(vortioxetine)
Study with vortioxetine on emotional functioning in patients with depression (COMPLETE) 2021 Interventional, open-label, flexible-dose study of vortioxetine on emotional symptoms in patients with major depressive disorder with inadequate response to SSRI/SNRI treatment 17797A

NCT03835715

2017-004829-33

Brintellix®
(vortioxetine)
Continuation with vortioxetine in child and adolescent patients with major depressive disorder (MDD) from 7 to 17 years of age 2020 Long-term, open-label, flexible-dose, continuation extension study with vortioxetine in child and adolescent patients with major depressive disorder (MDD) from 7 to 17 years of age 12712B

NCT03108625

2015-002658-11

Brintellix®
(vortioxetine)
Vortioxetine intravenous infusion at initiation of oral treatment with vortioxetine in patients with depression 2020 Interventional, randomised, double-blind, placebo-controlled study of the efficacy and safety of initial administration of 25 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with major depressive disorder 17915A

NCT03766867

2018-000992-34

Brintellix®
(vortioxetine)
Active reference (fluoxetine) fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years with major depressive disorder (MDD) 2019 Interventional, randomised, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years, with major depressive disorder (MDD) 12710A

NCT02709746

2008-005356-25

Brintellix®
(vortioxetine)
Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine (AtWoRC) 2018 Interventional, open-label, single cohort, Canadian study to describe the relationship between cognitive symptoms and work productivity in working adults treated with vortioxetine for Major Depressive Disorder 15913A

NCT02332954

EudraCT N/A

Brintellix®
(vortioxetine)
Investigating the Effect of Vortioxetine in Adult ADHD Patients 2017 Interventional, randomised, double-blind, placebo-controlled, fixed-dose study of vortioxetine in adults with Attention Deficit Hyperactivity Disorder (ADHD) 15996A

NCT02327013

EudraCT N/A

Brintellix®
(vortioxetine)
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder 2017 Interventional, randomised, double-blind, parallel-group study of the efficacy and safety of initial administration of 17 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with Major Depressive Disorder 16903A

NCT02919501

2015-005081-30

Brintellix®
(vortioxetine)
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder 2016 An interventional, randomised, double-blind, parallel-group, placebo-controlled study on the efficacy of vortioxetine on cognitive dysfunction in patients with partial or full remission of major depressive disorder 15905A

NCT02279953

2014-000229-19

Brintellix®
(vortioxetine)
Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder 2016 An interventional, randomised, double-blind, parallel-group, placebo-controlled, active-referenced (paroxetine), fixed-dose study on the efficacy of vortioxetine on cognitive dysfunction in working patients with major depressive disorder 15906A

NCT02279966

2014-000230-34

Brintellix®
(vortioxetine)
Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder 2016 An interventional, randomised, double-blind, parallel-group, active-comparator, flexible-dose study on the efficacy of vortioxetine versus escitalopram on cognitive dysfunction in patients with inadequate response to current antidepressant treatment of major depressive disorder 15907A

NCT02272517

2014-000231-16

Brintellix®
(vortioxetine)
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder 2015 An open-label study evaluating the pharmacokinetics and tolerability of Lu AA21004 in connection with multiple oral dosing of Lu AA21004 in child and adolescent patients with DSM-IV-TRTM diagnosis of depression or anxiety disorder 12708A

NCT01491035

2010-020170-42

Brintellix®
(vortioxetine)
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries 2014 A randomised, double-blind, parallel-group, active-comparator (venlafaxine extended release), fixed-dose study of Lu AA21004 in Major Depressive Disorder in Asian countries 13926A

NCT01571453

EudraCT N/A

Ebixa®
(memantine)
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer 2016 Interventional, randomised, double-blind, study to evaluate the safety and tolerability of once daily versus twice daily memantine treatment in patients with dementia of Alzheimer's type and MMSE range 5-18 14603A

NCT02553928

EudraCT N/A

Northera®
(droxidopa)
Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension (RESTORE) 2023 RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess sustained effecTs of dRoxidopa thErapy 16306A

NCT02586623

EudraCT N/A

Northera®
(droxidopa)
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy 2015 A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy 16305A

NCT01927055

EudraCT N/A

Onfi®
(clobazam)
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome 2016 A multi-site, prospective, open-label, long-term, flexible dose, interventional study to evaluate the safety and tolerability of clobazam as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome 14362B

NCT02187809

EudraCT N/A

Rexulti®
(brexpiprazole)
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment 2016 Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose long-term study to evaluate the maintenance of efficacy and safety of 1 to 3 mg/day of brexpiprazole as adjunctive treatment in patients with major depressive disorder with an inadequate response to antidepressant treatment 14570A

NCT01838681

2012-004169-42

Rexulti®
(brexpiprazole)
Brexpiprazole in Patients With Schizophrenia 2016 Interventional, open-label, flexible-dose extension study of brexpiprazole in patients with schizophrenia 14644B

NCT01810783

2012-002705-21

Rexulti®
(brexpiprazole)
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder 2016 Interventional, open-label, long-term extension study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in patients with major depressive disorder. 14767B

NCT01944969

2012-004169-42

Rexulti®
(brexpiprazole)
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD) 2016 Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose study of brexpiprazole as adjunctive treatment to paroxetine or sertraline in adult patients suffering from post-traumatic stress disorder (PTSD) 14865A

NCT01987960

2012-004982-41

Rexulti®
(brexpiprazole)
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment 2016 Interventional, open-label, flexible-dose, long-term study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to  antidepressant treatment 16160A

NCT02400346

2014-003547-35

Rexulti®
(brexpiprazole)
Brexpiprazole in Patients With Acute Schizophrenia 2015 Interventional, randomised, double-blind, parallel-group, placebo-controlled, active-reference, flexible-dose study of brexpiprazole in patients with acute schizophrenia 14644A

NCT01810380

2012-002252-17

Rexulti®
(brexpiprazole)
Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder 2015 Interventional, open-label, flexible-dose, exploratory study of brexpiprazole as adjunctive treatment of sleep disturbances in patients with major depressive disorder 15352A

NCT01942733

EudraCT N/A

Rexulti®
(brexpiprazole)
Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy 2015 Interventional, open-label, flexible-dose, exploratory study of brexpiprazole as adjunctive treatment of irritability in patients with major depressive disorder and an inadequate response to antidepressant therapy 15353A

NCT01942785

EudraCT N/A

Rexulti®
(brexpiprazole)
Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment 2014 Interventional, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of brexpiprazole (1 and 3 mg/day) as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to antidepressant treatment 14571A

NCT01837797

2012-001361-32

Sabril®
(vigabatrin)
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®) 2015 A prospective, open-label study of the structure and function of the retina in adult patients with refractory complex partial seizures treated with vigabatrin (Sabril®) 13098A

NCT01278173

EudraCT N/A

Selincro®
(nalmefene)
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use 2016 Exploratory, interventional, open-label, fixed dose study with Selincro® as-needed use, in alcohol dependent patients with liver impairment 15871A

NCT02197598

2014-000413-31

Selincro®
(nalmefene)
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care 2016 Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of
patients with alcohol dependence in primary care
15892A

NCT02195817

2013-004688-30

Vyepti® (eptinezumab) Real World Effectiveness of Eptinezumab in Participants With Migraine (EVEC) 2023 An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States 19766N

NCT05284019

EudraCT N/A

Vyepti®
(eptinezumab)
Eptinezumab in Adults With Migraine and Medication Overuse Headache (Sunlight) 2023 Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for the preventive treatment of migraine in patients with a dual diagnosis of migraine and medication overuse headache 19139A

NCT04772742

2020-001669-35

Vyepti®
(eptinezumab)
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments (DELIVER) 2023 Interventional, randomized, double-blind, parallel-group, placebo-controlled study with an extension period to evaluate the efficacy and safety of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments 18898A

NCT04418765

2019-004497-25

Vyepti®
(eptinezumab)
A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine (RELIEF) 2021 A parallel-group, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of eptinezumab administered intravenously in patients experiencing an acute attack of migraine 18903A

NCT04152083

EudraCT N/A

Vyepti®
(eptinezumab)
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PREVAIL) 2019 An open label phase 3 trial to evaluate the safety of ALD403 administered intravenously in patients with chronic migraine 19022A

NCT02985398

EudraCT N/A

Vyepti®
(eptinezumab)
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1) 2018 A Parallel Group Double-Blind Randomized Placebo Controlled Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Frequent Episodic Migraines 19016A

NCT02559895

EudraCT N/A

Vyepti®
(eptinezumab)
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2) 2018 A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Chronic Migraine 19020A

NCT02974153

2016-001306-41

Vyepti®
(eptinezumab)
A Multicenter Assessment of ALD403 in Chronic Migraine 2017 A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients with Chronic Migraine 19015A

NCT02275117

EudraCT N/A