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Trial record 3 of 15 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Latvia )

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

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ClinicalTrials.gov Identifier: NCT03766867
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief 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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Vortioxetine infusion 25 mg Drug: Vortioxetine tablets 10 mg/day Drug: Placebo infusion Drug: Placebo tablets Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vortioxetine 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

Drug: Vortioxetine tablets 10 mg/day
10 mg, tablets, oral administration once daily
Other Name: Brintellix ®

Placebo Comparator: Placebo Drug: Placebo infusion
concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose

Drug: Placebo tablets
oral administration once daily




Primary Outcome Measures :
  1. Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score [ Time Frame: From baseline (Day 0) to Day 1 (24 h post-infusion) ]
    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.


Secondary Outcome Measures :
  1. Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score [ Time Frame: From baseline (Day 0) to 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. 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.

  2. Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score [ Time Frame: From baseline (Day 0) to 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. 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.

  3. Change in MADRS total score from baseline to Day 1, Day 3, Day 7 [ Time Frame: 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.

  4. ≥50% decrease in MADRS total score from baseline on Day 1 and Day 3 [ Time Frame: 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.

  5. CGI-I score at Day 1, Day 3, Day 7 [ Time Frame: 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.

  6. CGI-I response (defined as CGI-I score ≤2) on Day 1 and 3 [ Time Frame: At 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.

  7. Change from baseline in CGI-S score to Day 1, Day 3, Day 7 [ Time Frame: From baseline 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).

  8. CL/F of vortioxetine [ Time Frame: Day 0, Day 1, Day 7 ]
    Total plasma clearance of vortioxetine

  9. Cav [ Time Frame: Day 0, Day 1, Day 7 ]
    average plasma concentration during a steady-state day



Information from the National Library of Medicine

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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 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


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): NCT03766867


Locations
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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, Bulgaria
Estonia
Marienthali Kliinik (EE2001)
Tallinn, Estonia
Tartu University Hospital (EE2002)
Tartu, Estonia
Latvia
Psychoneurological Hospital of Daugavpils (LV3003)
Daugavpils, Latvia
Riga Centre of Psychiatry and Narcology (LV3002)
Riga, Latvia
Psychoneurological Hospital of Strenci (LV3001)
Strenči, Latvia
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03766867     History of Changes
Other Study ID Numbers: 17915A
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Behavioral Symptoms
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