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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919501
• Other study ID #: 16903A
• Secondary ID: 2015-005081-30
• Status: Completed
• Phase: Phase 2
• Start date: September 27, 2016
• Est. completion date: April 27, 2017

Study information

• Verified date: June 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• Vortioxetine (IV)
17 mg, solution for infusion, administered, over 2 hours as single dose

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)

Locations

Country	Name	City	State
Estonia	EE1019	Tallinn
Estonia	EE1020	Tallinn
Finland	FI1040	Helsinki
Finland	FI1041	Helsinki
Finland	FI1030	Kuopio
Finland	FI1009	Pori
Finland	FI1027	Turku

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Takeda

Countries where clinical trial is conducted

Estonia,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Week 1
Secondary	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.	Baseline to Week 2
Secondary	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.	Baseline to Day 3
Secondary	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.	Baseline to Day 1
Secondary	Response (defined as a = 50% decrease in MADRS total score from baseline) at Week 1		Week 1
Secondary	Remission at Week 1 (defined as a MADRS total score = 10)		Week 1
Secondary	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.	baseline to Week 1
Secondary	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).	At Week 1
Secondary	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	Baseline to Week 1
Secondary	Oral clearance (CL/F)		2, 8 and 24 hours postdose (day 1) and day 14
Secondary	Average Plasma Concentration (Cav)		2, 8 and 24 hours postdose (day 1) and day 14
Secondary	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.	Baseline to Week 1

External Links

•   Results EudraCT 2015-005081-30