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

NCT02919501 | Completed Phase 2

• 2 other identifiers: 16903A2015-005081-30
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 7

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

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change from baseline to Week 2 in MADRS total score

  Baseline to Week 2

• Change from baseline to Day 3 in MADRS total score

  Baseline to Day 3

• Change from baseline to Day 1 in MADRS total score

  Baseline to Day 1

• Response (defined as a ≥ 50% decrease in MADRS total score from baseline) at Week 1

  Week 1

• Remission at Week 1 (defined as a MADRS total score ≤ 10)

  Week 1

Study Arms (2)

IV vortioxetine

EXPERIMENTAL

Drug: Vortioxetine (IV); Drug: Vortioxetine (tablet)

IV placebo

PLACEBO COMPARATOR

Other: Placebo (IV); Drug: Vortioxetine (tablet)

Interventions

Vortioxetine (IV) DRUG

17 mg, solution for infusion, administered, over 2 hours as single dose

IV vortioxetine

Placebo (IV) OTHER

Saline: isotonic sodium chloride, administered, over 2 hours as single dose

IV placebo

Vortioxetine (tablet) DRUG

10 mg, tablets, oral administration once daily for 15 days (open labelled)

IV placebo; IV vortioxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Takeda: collaborator

Study Sites (7)

EE1019

Tallinn, Estonia

Location

EE1020

Tallinn, Estonia

Location

FI1040

Helsinki, Finland

Location

FI1041

Helsinki, Finland

Location

FI1030

Kuopio, Finland

Location

FI1009

Pori, Finland

Location

FI1027

Turku, Finland

Location

Related Publications (1)

• 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.

  PMID: 31094901 DERIVED

Related Links

• Results EudraCT 2015-005081-30

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine; Tablets

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 29, 2016
• Study Start: September 27, 2016
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

ES (2); FI (5)