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Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT02709655
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric patients (age 7 to 11 years)

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Vortioxetine 10 mg/day Drug: Vortioxetine 20 mg/day Drug: Fluoxetine 20mg/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 7 to 11 Years With Major Depressive Disorder (MDD)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vortioxetine 10 mg/day Drug: Vortioxetine 10 mg/day

10 mg/day, encapsulated tablet, orally (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, orally (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 20mg/day

20 mg/day, encapsulated tablet, orally (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, orally



Primary Outcome Measures :
  1. Change in CDRS-R total score after treatment [ Time Frame: Baseline to Week 12 ]
    Children Depression Rating Scale -- Revised (CDRS-R)


Secondary Outcome Measures :
  1. Change in CDRS-R total score during treatment [ Time Frame: Baseline to Week 12 ]
    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 in General Behaviour Inventory (GBI), using the 10-item depression subscale [ Time Frame: Baseline to Week 12 ]
  5. Change in PGA score [ Time Frame: Baseline to Week 12 ]
    Parent Global Assessment - global Improvement

  6. Change in CGI-S score [ Time Frame: Baseline to Week 12 ]
    Clinical Global Impression - Severity of Illness

  7. Change in CGI-I score [ Time Frame: Baseline to Week 12 ]
    Clinical Global Impression - Global Improvement

  8. 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

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

  10. Change in CGAS score [ Time Frame: Baseline to Week 12 ]
    Children's Global Assessment Scale (CGAS)

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

  12. Change in PQ-LES-Q score [ Time Frame: Baseline to Week 12 ]
    Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
  2. The patient has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
  3. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and the Baseline.
  4. The patient is a boy or girl, aged ≥7 and <12 years at Screening Visit
  5. The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion Criteria:

  1. The patient has participated in a clinical study <30 days prior to the Screening Visit.
  2. The patient has previously participated in a study with vortioxetine.

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): NCT02709655


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

  Show 129 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Takeda
Investigators
Study Director: Email contact via Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02709655     History of Changes
Other Study ID Numbers: 12709A
2008-005353-38 ( EudraCT Number )
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Keywords provided by H. Lundbeck A/S:
paediatric

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