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Trial record 2 of 11 for:    lundbeck gainesville

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

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ClinicalTrials.gov Identifier: NCT02709746
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Vortioxetine 10 mg/day Drug: Vortioxetine 20 mg/day Drug: Fluoxetine 20 mg/day Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • Brintellix ®
  • Lu AA21004

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:
  • Brintellix ®
  • Lu AA21004

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

Placebo Comparator: Placebo Other: Placebo
Encapsulated tablet




Primary Outcome Measures :
  1. Change in CDRS-R total score after treatment [ Time Frame: Baseline to week12 ]
    Children Depression Rating Scale -- Revised (CDRS-R)


Secondary Outcome Measures :
  1. Change in CDRS-R total score during treatment [ Time Frame: Baseline to week12 ]
    Children Depression Rating Scale -- Revised (CDRS-R)

  2. CDRS-R response (defined as >50% reduction in the CDRS-R total score (subtracted 17 points)) [ Time Frame: 12 weeks ]
    Children Depression Rating Scale -- Revised (CDRS-R)

  3. remission (defined as CDRS-R <28), at each visit assessed [ Time Frame: 12 weeks ]
    Children Depression Rating Scale -- Revised (CDRS-R)

  4. Change from baseline in the General Behaviour Inventory (GBI), using the 10-item depression subscale [ Time Frame: Baseline to week12 ]
  5. Change in PGA score [ Time Frame: Baseline to week12 ]
    Parent Global Assessment - global Improvement

  6. Change in SDMT (number of correct numbers) [ Time Frame: Baseline to week12 ]
    The Symbol Digit Modalities Test (SDMT)

  7. Change in CGI-S score [ Time Frame: Baseline to week12 ]
    Clinical Global Impression - Severity of Illness

  8. Change in CGI-I score [ Time Frame: Baseline to week12 ]
    Clinical Global Impression - Global Improvement

  9. Remission in the CGI-S score (defined as a CGI-S score of 1or 2) at each visit assessed [ Time Frame: 12 weeks ]
    Clinical Global Impression - Severity of Illness

  10. Response in the CGI-I score (defined as a CGI-I score of 1or 2) [ Time Frame: 12 weeks ]
    Clinical Global Impression - Global Improvement

  11. Change in CGAS score [ Time Frame: Baseline to week12 ]
    Children's Global Assessment Scale (CGAS)

  12. Change in PedsQL VAS score [ Time Frame: Baseline to week12 ]
    PedsQL Present Functioning Visual Analogue Scales

  13. Change in PQ-LES-Q score [ Time Frame: Baseline to week12 ]
    Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 CDRS-R total score ≥45 at the Screening Visit and at the Baseline.
  • The patient has a 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709746


Contacts
Contact: Email contact via H.Lundbeck A/S +4536301311 LundbeckClinicalTrials@Lundbeck.com

  Show 132 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Takeda
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02709746     History of Changes
Other Study ID Numbers: 12710A
2008-005354-20 ( EudraCT Number )
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Keywords provided by H. Lundbeck A/S:
paediatric patients

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Fluoxetine
Vortioxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists