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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

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ClinicalTrials.gov Identifier: NCT02919501
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Vortioxetine (IV) Other: Placebo (IV) Drug: Vortioxetine (tablet) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : April 27, 2017
Actual Study Completion Date : April 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV vortioxetine Drug: Vortioxetine (IV)
17 mg, solution for infusion, administered, over 2 hours as single dose

Drug: Vortioxetine (tablet)
10 mg, tablets, oral administration once daily for 15 days (open labelled)

Placebo Comparator: IV placebo Other: Placebo (IV)
Saline: isotonic sodium chloride, administered, over 2 hours as single dose

Drug: Vortioxetine (tablet)
10 mg, tablets, oral administration once daily for 15 days (open labelled)




Primary Outcome Measures :
  1. Change from baseline to Week 1 in MADRS total score [ Time Frame: Baseline to Week 1 ]
    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.


Secondary Outcome Measures :
  1. Change from baseline to Week 2 in MADRS total score [ Time Frame: Baseline to Week 2 ]
    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

  2. Change from baseline to Day 3 in MADRS total score [ Time Frame: Baseline to Day 3 ]
    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

  3. Change from baseline to Day 1 in MADRS total score [ Time Frame: Baseline to Day 1 ]
    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

  4. Response (defined as a ≥ 50% decrease in MADRS total score from baseline) at Week 1 [ Time Frame: Week 1 ]
  5. Remission at Week 1 (defined as a MADRS total score ≤ 10) [ Time Frame: Week 1 ]
  6. Change from baseline to Week 1 in HADS depression subscale [ Time Frame: baseline to Week 1 ]
    The Hospital Anxiety and Depression Scale (HADS) is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21.

  7. Global clinical impression -Global Improvement [ Time Frame: At Week 1 ]
    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).

  8. Change from baseline in Global clinical impression -Severity [ Time Frame: Baseline to Week 1 ]
    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

  9. Oral clearance (CL/F) [ Time Frame: 2, 8 and 24 hours postdose (day 1) and day 14 ]
  10. Average Plasma Concentration (Cav) [ Time Frame: 2, 8 and 24 hours postdose (day 1) and day 14 ]
  11. Change from baseline to Week 1 in HADS anxiety subscale [ Time Frame: Baseline to Week 1 ]
    The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has recurrent Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM-5™), classification code (296.3x). The recurrent Major Depressive Episode (MDE) should be confirmed using the Mini-International Neuropsychiatric Interview (MINI).
  • The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥30 at both Screening and Baseline Visits.
  • The patient has had the current MDE for ≥3 months

Exclusion Criteria:

  • The patient has any current psychiatric disorder or Axis I disorder (DSM-5™ criteria), other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI).
  • The patient has a current diagnosis of history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-5™ criteria).
  • The patient suffers from personality disorders, intellectual disability, pervasive development disorder, attention deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ criteria).
  • The patient has a history of lack of response to previous treatment with vortioxetine (including current episode).

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): NCT02919501


Locations
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Estonia
EE1019
Tallinn, Estonia
EE1020
Tallinn, Estonia
Finland
FI1040
Helsinki, Finland
FI1041
Helsinki, Finland
FI1030
Kuopio, Finland
FI1009
Pori, Finland
FI1027
Turku, Finland
Sponsors and Collaborators
H. Lundbeck A/S
Takeda
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02919501     History of Changes
Other Study ID Numbers: 16903A
2015-005081-30 ( EudraCT Number )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Behavioral Symptoms
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists