Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)

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)

Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Vortioxetine 10 mg/day; Drug: Vortioxetine 20 mg/day; Drug: Fluoxetine 20 mg/day; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 784
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Targovishte, Bulgaria
    • BG1023
  • Varna, Bulgaria
    • BG1025
• Canada
  • Calgary, Canada
    • CA1036 University of Calgary
  • Toronto, Canada
    • CA1038
• Colombia
  • Barranquilla, Colombia
    • CO1003
  • Bello, Colombia
    • CO1001
  • Bogotá, Colombia
    • CO1004
  • Pereira, Colombia
    • CO1002
• Estonia
  • Tallinn, Estonia
    • EE1007
  • Viljandi, Estonia
    • EE1015
• France
  • Douai, France
    • FR1041
  • Elancourt, France
    • FR1017
  • Nantes, France
    • FR1009
• Germany
  • Freiburg, Germany
    • DE1078
  • Mainz, Germany
    • DE1034
  • Mannheim, Germany
    • DE1077
  • Maulbronn, Germany
    • DE1081
  • Tübingen, Germany
    • DE1076
• Hungary
  • Budapest, Hungary
    • HU1023
  • Gyula, Hungary
    • HU1020
• Italy
  • Cagliari, Italy
    • IT1075
  • Genova, Italy
    • IT1073
  • Messina, Italy
    • IT1029
  • Napoli, Italy
    • IT1068
  • Padova, Italy
    • IT1074
  • Pisa, Italy
    • IT1070
  • Rome, Italy
    • IT1072 Osppedale Bambin gesu
• Korea, Republic of
  • Cheonan, Korea, Republic of
    • KR1035
  • Gyeongsang, Korea, Republic of
    • UA1037
  • Seoul, Korea, Republic of
    • KR1032
  • Seoul, Korea, Republic of
    • KR1038
• Latvia
  • Jelgava, Latvia
    • LV1002
  • Liepaja, Latvia
    • LV1008
  • Riga, Latvia
    • LV1009
  • Sigulda, Latvia
    • LV1007
• Mexico
  • Ciudad de mexico, Mexico
    • MX1003
  • Culiacán, Mexico
    • MX1014
  • Guadalajara, Mexico
    • MX1011
  • Guadalajara, Mexico
    • MX1013
  • Guadalajara, Mexico
    • MX1022
  • Mazatlán, Mexico
    • MX1023
  • Nuevo León, Mexico
    • MX1001
• Poland
  • Bialystok, Poland
    • PL1002
  • Gdansk, Poland
    • PL1050
  • Kielce, Poland
    • PL1068
  • Lublin, Poland
    • PL1057
  • Poznan, Poland
    • PL1052
  • Wroclaw, Poland
    • PL1051
  • Wąbrzeźno, Poland
    • PL1054
• Russian Federation
  • Arkhangel'sk, Russian Federation
    • RU1009
  • Ekaterinburg, Russian Federation
    • RU1016
  • Engel's, Russian Federation
    • RU1059
  • Krasnodar, Russian Federation
    • RU1046
  • Lipetsk, Russian Federation
    • RU1011
  • Nizhniy Novgorod, Russian Federation
    • RU1004
  • Novosibirsk, Russian Federation
    • RU1010
  • Rostov on Don, Russian Federation
    • RU1012
  • Rostov-na-Donu, Russian Federation
    • RU1044
  • Saratov, Russian Federation
    • RU1013
  • Saratov, Russian Federation
    • RU1038
  • St.Petersburg, Russian Federation
    • RU1030
  • Tomsk, Russian Federation
    • RU1057
  • Tonnel'nyy, Russian Federation
    • RU1048
• Serbia
  • Belgrad, Serbia
    • RS1010
  • Belgrade, Serbia
    • RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents
  • Kragujevac, Serbia
    • RS1011
  • Niš, Serbia
    • RS1003
  • Novi Sad, Serbia
    • RS1007
• South Africa
  • Cape Town, South Africa
    • ZA1019
  • Randburg, South Africa
    • ZA1022
  • Sandton, South Africa
    • ZA1023
• Spain
  • Alcorcon, Spain
    • ES1041
  • Madrid, Spain
    • ES1044
  • Pamplona, Spain
    • ES1043
  • Sabadell, Spain
    • ES1018 Hospital de Sabadell
  • Torremolinos, Spain
    • ES1040
• Ukraine
  • Kyiv, Ukraine
    • UA1002
  • Odessa, Ukraine
    • UA1019
  • Poltava, Ukraine
    • UA1001
  • Ternopil', Ukraine
    • UA1004
• United Kingdom
  • Glasgow, United Kingdom
    • GB1051
  • Liverpool, United Kingdom
    • GB1047
• United States
  • Alabama
    • Dothan, Alabama, United States
      • US1369
  • Arizona
    • Tucson, Arizona, United States
      • US1333
  • Arkansas
    • Little Rock, Arkansas, United States
      • US1310
  • California
    • Costa Mesa, California, United States
      • US1062
    • Downey, California, United States
      • US1387
    • Escondido, California, United States
      • US1114
    • Glendale, California, United States
      • US1118
    • Imperial, California, United States
      • US1123
    • Long Beach, California, United States
      • US1160 Renew Behavioral Health, Inc.
    • Orange, California, United States
      • US1368
    • Panorama City, California, United States
      • US1370
    • Wildomar, California, United States
      • US1351
  • District of Columbia
    • Washington, District of Columbia, United States
      • US1133
  • Florida
    • Gainesville, Florida, United States
      • US1217
    • Orange City, Florida, United States
      • US1229
  • Georgia
    • Atlanta, Georgia, United States
      • US1009
    • Marietta, Georgia, United States
      • US1313
  • Illinois
    • Naperville, Illinois, United States
      • US1311
    • Naperville, Illinois, United States
      • US1315
    • Oak Brook, Illinois, United States
      • US1103
  • Kansas
    • Wichita, Kansas, United States
      • US1386
  • Louisiana
    • Lake Charles, Louisiana, United States
      • US1261
  • Maryland
    • Baltimore, Maryland, United States
      • US1015
  • Mississippi
    • Clinton, Mississippi, United States
      • US1385 Ericksen Research And Development
  • Missouri
    • Creve Coeur, Missouri, United States
      • US1064
    • O'Fallon, Missouri, United States
      • US1314
    • Saint Charles, Missouri, United States
      • US1266
  • New Jersey
    • Berlin, New Jersey, United States
      • US1312
    • Princeton, New Jersey, United States
      • US1222
  • New York
    • New York, New York, United States
      • US1317
    • Rochester, New York, United States
      • US1171
    • Staten Island, New York, United States
      • US1190
  • Ohio
    • Cincinnati, Ohio, United States
      • US1051
    • Cleveland, Ohio, United States
      • US1054
    • Middleburg Heights, Ohio, United States
      • US1334
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • US1323
    • Oklahoma City, Oklahoma, United States
      • US1329
  • Texas
    • Austin, Texas, United States
      • US1328
    • Plano, Texas, United States
      • US1320
    • San Antonio, Texas, United States
      • US1162
  • Utah
    • Orem, Utah, United States
      • US1308
  • Virginia
    • Richmond, Virginia, United States
      • US1309

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study).
• The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
• The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline.
• The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline
• The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion Criteria:

• The patient has participated in a clinical study <30 days prior to the Screening Visit.

Other protocol defined inclusion and exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Encapsulated tablet
Experimental: Vortioxetine 10 mg/day	Drug: Vortioxetine 10 mg/day; 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; Other Names: Lu AA21004; Brintellix ®
Experimental: Vortioxetine 20 mg/day	Drug: Vortioxetine 20 mg/day; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; Other Names: Lu AA21004; Brintellix ®
Active Comparator: Fluoxetine 20 mg/day,	Drug: Fluoxetine 20 mg/day; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment	The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).	From Randomization to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CDRS-R Total Score During Treatment (at Week 2)	The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).Children and parents answer separately. Rater judges and selects 'Best'.	At week 2
Change in CDRS-R Total Score During Treatment (at Week 4)	The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).	At week 4
Change in CDRS-R Total Score During Treatment (at Week 6)	The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).	At week 6
Change in CDRS-R Mood Score	Change in Children Depression Rating Scale - Revised (CDRS-R) Mood. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Mood is one of four subscores defined in the CDRS-R: sum of items 8, 11, 14, 15; score range 4 to 28. The highest possible score indicates the most severe measure of depression.	From randomization to Week 8
Change in CDRS-R Somatic Score	Change in Children Depression Rating Scale - Revised (CDRS-R): Somatic. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Somatic is one of four subscores defined in the CDRS-R: sum of items 4, 5, 6, 7, 16, 17; score ranges from 6 to 36. The highest possible score indicates the most severe measure of depression.	From Randomization to Week 8
Change in CDRS-R Subjective Score	Change in Children Depression Rating Scale - Revised (CDRS-R): Subjective. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Subjective is one of four subscores defined in the CDRS-R: sum of items 9, 10, 12, 13; score ranges from 4 to 28. The highest possible score indicates the most severe measure of depression.	From Randomization to Week 8
Change in CDRS-R Behaviour Score	Change in Children Depression Rating Scale - Revised (CDRS-R): Behaviour. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. behaviour is one of four subscores defined in the CDRS-R:sum of items 1, 2, 3; score ranges from 3 to 21. The highest possible score indicates the most severe measure of depression.	From Randomization to Week 8
CDRS-R Response	Children Depression Rating Scale - Response: defined as a >= 50% decrease in CDRS-R total score, calculated as (change from baseline [Randomization])/(baseline value - 17).	From Randomization to Week 8
CDRS-R Remission	Remission is defined as a CDRS-R total score <= 28.	From Randomization to Week 8
Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents	Using the 10-item depression subscale, assessed by parent (PGBI-10D). Change from randomization to Week 8 in GBI Total Parent/Guardian Version Depression score. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.	From randomization to week 8
Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child	The GBI 10-item mania scale is a parent- and subject-rated scale designed to screen for manic symptoms in children and adolescents. The 10 items are rated on a scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranges from 0 to 30 points, with high scores indicating greater pathology.	From randomization to Week 8
Parent Global Assessment-Global Improvement (PGA) Score	The PGA is a parent-rated variation of the CGI-I to evaluate the severity of the child's symptoms. The PGA reflects assessments of change from Baseline symptoms using a 7 point scale ranging from 1 (very much improved) to 7 (very much worse).	From Randomization to Week 8
Change in Symbol Digit Modalities Test (SDMT)	The Symbol Digit Modalities Test (SDMT) is a cognitive test designed to assess speed of performance requiring visual perception, spatial decision-making and psychomotor skills. The SDMT consists of 110 geometric symbols that the patient has to substitute with a corresponding digit in a 90-second period. Each correct digit is counted, and the total score ranges from 0 (less than normal functioning) to 110 (greater than normal functioning).	From Randomization to Week 8
Change in Clinical Global Impression Severity of Illness (CGI-S) Score	The 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 Randomization to Week 8
Clinical Global Impression - Global Improvement (CGI-I) Score	The 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). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.	From Randomization to Week 8
CGI-S Remission	Remission defined as CGI-S score of 1 or 2.	From Randomization to Week 8
Change in Children's Global Assessment Scale (CGAS) Score	The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children. The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The items range in value from 1 (most functionally impaired child) to 100 (the healthiest). A total score above 70 indicates normal function.	From Randomization to Week 8
Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome.	From Randomization to Week 8
Change in PedsQL VAS: Sad or Blue (Sadness) Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome.	From Randomization to Week 8
Change in PedsQL VAS: Angry Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome.	From Randomization to Week 8
Change in PedsQL VAS: Worry Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome.	From Randomization to Week 8
Change in PedsQL VAS: Tired (Fatigue) Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome.	From Randomization to week 8
Change in PedsQL VAS: Pain or Hurt Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. A lower value represents a better outcome.	From Randomization to Week 8
Change in PedsQL VAS Total Average Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using visual analogue scales. The functionality for each domain is measured on a 10cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. The total score is the average of all 6 items. A lower value represents a better outcome.	From Randomization to week 8
Change in PedsQL Emotional Distress Summary Average Score	The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue and pain using visual analogue scales. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The patients are asked to mark on the line how they feel. The average emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome.	From Randomization to week 8
Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores	PQ-LES-Q total score (items 1 to 14). The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), which is used to measure quality of life in adults. The PQ LES Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning (and item 15 allows subjects to summarize their experience in a global rating). Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1-14 (this outcome measurement) is 14 to 70, with higher scores indicating greater satisfaction.	From Randomization to Week 8
Change in PQ-LES-Q Overall Score	PQ-LES-Q overall evaluation score (item 15). The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning and item 15 allows subjects to summarize their experience in a global rating (this outcome measurement). Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good).	From Randomization to Week 8

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Collaborators: Takeda

Publications and helpful links

General Publications

• Findling RL, DelBello MP, Zuddas A, Emslie GJ, Ettrup A, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study. J Am Acad Child Adolesc Psychiatry. 2022 Sep;61(9):1106-1118.e2. doi: 10.1016/j.jaac.2022.01.004. Epub 2022 Jan 13.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: paediatric patients
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine; Fluoxetine
• Other Study ID Numbers: 12710A; 2008-005354-20 (EudraCT Number)