Major Depressive DisorderPhase 2NCT03766867
Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression
A Phase 2 study testing Vortioxetine infusion 25 mg and Vortioxetine tablets 10 mg/day in people with Major Depressive Disorder, run by H. Lundbeck A/S at 13 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vortioxetine infusion 25 mg and Vortioxetine tablets 10 mg/day
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 3 Dec 2018to 28 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -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
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Bulgaria8 sites
Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD (BG1004)
Burgas
SPH - Kardzhali, EOOD (BG1005)
Kardzhali
MHAT "Dr. Hristo Stambolski", EOOD (BG1001)
Kazanlak
State Psychiatric Hospital "Sv. Ivan Rilski" (BG1009)
Novi Iskar
UMHAT 'Dr. Georgi Stranski', EAD (BG1006)
Pleven
MHC - Ruse, EOOD (BG1007)
Rousse
State Psychiatric Hospital (BG1008)
Tsarev Brod
Mental Health Center-Vratsa EOOD (BG1002)
Vratsa
Latvia3 sites
Psychoneurological Hospital of Daugavpils (LV3003)
Daugavpils
Riga Centre of Psychiatry and Narcology (LV3002)
Riga
Psychoneurological Hospital of Strenci (LV3001)
Strenči
Estonia2 sites
Marienthali Kliinik (EE2001)
Tallinn
Tartu University Hospital (EE2002)
Tartu
About this study
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
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
Read the detailed description
The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine infusion 25 mg, Vortioxetine tablets 10 mg/day, Placebo infusion, Placebo tablets
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine infusion 25 mgDrug
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/dayDrug
Also called Brintellix ®
10 mg, tablets, oral administration once daily
Placebo infusionDrug
concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
Placebo tabletsDrug
oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | Not described Receives: Drug: Vortioxetine infusion 25 mg; Drug: Vortioxetine tablets 10 mg/day |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo infusion; Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (Day 0) to Day 1 (24 h post-infusion)
Secondary outcomes (9)
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.
Measured: From baseline (Day 0) to Day 3
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.
Measured: From baseline (Day 0) to Day 7
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.
Measured: From baseline to Day 1, Day 3, Day 7
≥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.
Measured: On Day 1 and Day 3
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.
Measured: At Day 1, Day 3, Day 7
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.
Measured: At Day 1 and 3
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).
Measured: From baseline to Day 1, Day 3, Day 7
CL/F of vortioxetine
Total plasma clearance of vortioxetine
Measured: Day 0, Day 1, Day 7
Cav
average plasma concentration during a steady-state day
Measured: Day 0, Day 1, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start3 Dec 2018
- Primary completion31 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766867
- Sponsor's protocol ID
- 17915A
- Status last verified
- Jun 2019
- First submitted
- 5 Dec 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rancans E, Zambori J, Dalsgaard M, Baayen C, Areberg J, Ettrup A, Florea I. Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study. Int Clin Psychopharmacol. 2020 Nov;35(6):305-312. doi: 10.1097/YIC.0000000000000326.
PubMed 32784346
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03766867
- Acronym / sponsor ID
- 17915A
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: Vortioxetine infusion 25 mg, Drug: Vortioxetine tablets 10 mg/day |
| Placebo | Placebo comparator | Drug: Placebo infusion, Drug: Placebo tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine infusion 25 mg1 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 |
| Vortioxetine tablets 10 mg/dayAlso: Brintellix ®10 mg, tablets, oral administration once daily | Drug | Vortioxetine |
| Placebo infusionconcentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose | Drug | Placebo |
| Placebo tabletsoral administration once daily | Drug | Placebo |
Primary outcome
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.
9 secondary outcomes
Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score
Time frame: From baseline (Day 0) to Day 3
Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score
Time frame: From baseline (Day 0) to Day 7
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
≥50% decrease in MADRS total score from baseline on Day 1 and Day 3
Time frame: On Day 1 and Day 3
CGI-I score at Day 1, Day 3, Day 7
Time frame: At Day 1, Day 3, Day 7
CGI-I response (defined as CGI-I score ≤2) on Day 1 and 3
Time frame: At Day 1 and 3
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
CL/F of vortioxetine
Time frame: Day 0, Day 1, Day 7
Cav
Time frame: Day 0, Day 1, Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Derived from this study: PubMed 32784346Rancans E, Zambori J, Dalsgaard M, Baayen C, Areberg J, Ettrup A, Florea I. Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study. Int Clin Psychopharmacol. 2020 Nov;35(6):305-312. doi: 10.1097/YIC.0000000000000326.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vortioxetine infusion 25 mg and Vortioxetine tablets 10 mg/day in people with Major Depressive Disorder, run by H. Lundbeck A/S at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Bulgaria, Latvia, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.