Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression

Major Depressive Disorder Clinical Trial

Official title:

Interventional, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Initial Administration of 25 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766867
• Other study ID #: 17915A
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2018
• Est. completion date: August 28, 2019

Study information

• Verified date: June 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days

Description:

The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 28, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patient has recurrent MDD, diagnosed according to DSM-5® and confirmed using the Mini-International Neuropsychiatric Interview (MINI).

• The patient has a MADRS total score = 30 at the Screening Visit.

• As part of standard of care treatment, the patient is to be admitted to hospital due to the severity of the depressive symptoms and is willing to remain hospitalized for the duration of the study treatment period.

• The patient has had the current MDE for =3 months but less than 12 months.

• The patient has received treatment for the current episode with an SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, sertraline) at an approved dose for at least 6 weeks.

Exclusion criteria:

-The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the MINI or another diagnostic interview

Other in- and exclusion criteria may apply

Related Conditions & MeSH terms

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

Intervention

Drug:
• Vortioxetine infusion 25 mg
1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days
• Vortioxetine tablets 10 mg/day
10 mg, tablets, oral administration once daily
• Placebo infusion
concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
• Placebo tablets
oral administration once daily

Locations

Country	Name	City	State
Bulgaria	Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD (BG1004)	Burgas
Bulgaria	SPH - Kardzhali, EOOD (BG1005)	Kardzhali
Bulgaria	MHAT "Dr. Hristo Stambolski", EOOD (BG1001)	Kazanlak
Bulgaria	State Psychiatric Hospital "Sv. Ivan Rilski" (BG1009)	Novi Iskar
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD (BG1006)	Pleven
Bulgaria	MHC - Ruse, EOOD (BG1007)	Ruse
Bulgaria	State Psychiatric Hospital (BG1008)	Tsarev Brod
Bulgaria	Mental Health Center-Vratsa EOOD (BG1002)	Vratsa
Estonia	Marienthali Kliinik (EE2001)	Tallinn
Estonia	Tartu University Hospital (EE2002)	Tartu
Latvia	Psychoneurological Hospital of Daugavpils (LV3003)	Daugavpils
Latvia	Riga Centre of Psychiatry and Narcology (LV3002)	Riga
Latvia	Psychoneurological Hospital of Strenci (LV3001)	Strenci

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Bulgaria,  Estonia,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score	The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The primary endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.	From baseline (Day 0) to Day 1 (24 h post-infusion)
Secondary	Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score	The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.	From baseline (Day 0) to Day 3
Secondary	Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score	The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.	From baseline (Day 0) to Day 7
Secondary	Change in MADRS total score from baseline to Day 1, Day 3, Day 7	The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60.	From baseline to Day 1, Day 3, Day 7
Secondary	=50% decrease in MADRS total score from baseline on Day 1 and Day 3	The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60.	On Day 1 and Day 3
Secondary	CGI-I score at Day 1, Day 3, Day 7	The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The 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). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.	At Day 1, Day 3, Day 7
Secondary	CGI-I response (defined as CGI-I score =2) on Day 1 and 3	The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The 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). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.	At Day 1 and 3
Secondary	Change from baseline in CGI-S score to Day 1, Day 3, Day 7	The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The 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).	From baseline to Day 1, Day 3, Day 7
Secondary	CL/F of vortioxetine	Total plasma clearance of vortioxetine	Day 0, Day 1, Day 7
Secondary	Cav	average plasma concentration during a steady-state day	Day 0, Day 1, Day 7