search
Back to results

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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vortioxetine (IV)
Placebo (IV)
Vortioxetine (tablet)
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • EE1019
  • EE1020
  • FI1040
  • FI1041
  • FI1030
  • FI1009
  • FI1027

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV vortioxetine

IV placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to Week 1 in MADRS total score
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

Change from baseline to Week 2 in MADRS total score
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.
Change from baseline to Day 3 in MADRS total score
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.
Change from baseline to Day 1 in MADRS total score
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.
Response (defined as a ≥ 50% decrease in MADRS total score from baseline) at Week 1
Remission at Week 1 (defined as a MADRS total score ≤ 10)
Change from baseline to Week 1 in HADS depression subscale
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.
Global clinical impression -Global Improvement
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).
Change from baseline in Global clinical impression -Severity
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
Oral clearance (CL/F)
Average Plasma Concentration (Cav)
Change from baseline to Week 1 in HADS anxiety subscale
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.

Full Information

First Posted
September 28, 2016
Last Updated
June 18, 2018
Sponsor
H. Lundbeck A/S
Collaborators
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT02919501
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 27, 2016 (Actual)
Primary Completion Date
April 27, 2017 (Actual)
Study Completion Date
April 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV vortioxetine
Arm Type
Experimental
Arm Title
IV placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vortioxetine (IV)
Intervention Description
17 mg, solution for infusion, administered, over 2 hours as single dose
Intervention Type
Other
Intervention Name(s)
Placebo (IV)
Intervention Description
Saline: isotonic sodium chloride, administered, over 2 hours as single dose
Intervention Type
Drug
Intervention Name(s)
Vortioxetine (tablet)
Intervention Description
10 mg, tablets, oral administration once daily for 15 days (open labelled)
Primary Outcome Measure Information:
Title
Change from baseline to Week 1 in MADRS total score
Description
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.
Time Frame
Baseline to Week 1
Secondary Outcome Measure Information:
Title
Change from baseline to Week 2 in MADRS total score
Description
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.
Time Frame
Baseline to Week 2
Title
Change from baseline to Day 3 in MADRS total score
Description
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.
Time Frame
Baseline to Day 3
Title
Change from baseline to Day 1 in MADRS total score
Description
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.
Time Frame
Baseline to Day 1
Title
Response (defined as a ≥ 50% decrease in MADRS total score from baseline) at Week 1
Time Frame
Week 1
Title
Remission at Week 1 (defined as a MADRS total score ≤ 10)
Time Frame
Week 1
Title
Change from baseline to Week 1 in HADS depression subscale
Description
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.
Time Frame
baseline to Week 1
Title
Global clinical impression -Global Improvement
Description
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).
Time Frame
At Week 1
Title
Change from baseline in Global clinical impression -Severity
Description
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
Time Frame
Baseline to Week 1
Title
Oral clearance (CL/F)
Time Frame
2, 8 and 24 hours postdose (day 1) and day 14
Title
Average Plasma Concentration (Cav)
Time Frame
2, 8 and 24 hours postdose (day 1) and day 14
Title
Change from baseline to Week 1 in HADS anxiety subscale
Description
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.
Time Frame
Baseline to Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
EE1019
City
Tallinn
Country
Estonia
Facility Name
EE1020
City
Tallinn
Country
Estonia
Facility Name
FI1040
City
Helsinki
Country
Finland
Facility Name
FI1041
City
Helsinki
Country
Finland
Facility Name
FI1030
City
Kuopio
Country
Finland
Facility Name
FI1009
City
Pori
Country
Finland
Facility Name
FI1027
City
Turku
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31094901
Citation
Vieta E, Florea I, Schmidt SN, Areberg J, Ettrup A. Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 2-week, randomized, double-blind, placebo-controlled study. Int Clin Psychopharmacol. 2019 Jul;34(4):153-160. doi: 10.1097/YIC.0000000000000271.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/ctr-search/trial/2015-005081-30/results
Description
Results EudraCT 2015-005081-30

Learn more about this trial

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

We'll reach out to this number within 24 hrs