Major Depressive DisorderPhase 4NCT04288895
Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 24 sites in India.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of flexible doses of vortioxetine (5 - 20 mg/day) over a period of 12 weeks in patients with depression in India 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 24 sitesIndia
- Study dates
- 20 Feb 2020to 12 Mar 2022
- Phase
- Phase 4
- 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 a Major Depressive Episode (MDE), is diagnosed with Major Depressive Disorder (MDD) according to DSM-5® and would benefit from pharmacological treatment with vortioxetine. The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a CGI-S ≥4 at screening.
Who cannot join
- The patient has a significant risk of suicide according to investigator's clinical judgment or has made an actual suicide attempt in the period of 6 months prior to screening.
- The patient previously received vortioxetine.
- Other in- and exclusion criteria may apply.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
India24 sites
Ratandeep Multispecialty Hospital (IN1002)
Ahmedabad, Gujarat, 380008
MITR Foundation 1 (IN1013)
Ahmedabad, Gujarat, 380013
BJ Medical College and Civil Hospital (IN028)
Ahmedabad, Gujarat, 380016
People Tree Hospitals (IN1027)
Bengaluru, Karnataka, 560 022
Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)
Chhatrapati Sambhajinagar, Maharashtra, 431005
Maharaja Agarsen Hospital (IN1021)
Delhi, 110026
ASHA hospital (IN1018)
Hyderabad, Telangana, 500034
Shree Hatkesh Health Foundation (IN1016)
Jūnāgadh, Gujarat, 362001
Institute of Post Graduate Medical Education and Research (IN1026)
Kolkata, West Bengal, 700020
IQRAA International Hospital & Research Centre (IN030)
Kozhikode, Kerala, 673009
Dayanand Medical College and Hospital (IN024)
Ludhiana, Punjab, 141001
Vinaya Hospital & Research Centre (IN1007)
Mangalore, Karnataka, 575 003
Mangala Hospital & Mangala Kidney Foundation (IN1006)
Mangalore, Karnataka, 575003
K. S. Hegde Medical Academy (IN1003)
Mangalore, Karnataka, 575018
Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)
Mysuru, Karnataka, 570001
Arneja Heart and Multispeciality Hospital (IN1022)
Nagpur, Maharashtra, 440010
Central Institute of Behavioural Sciences (IN1019)
Nagpur, Maharashtra, 440010
Chopda Medicare & Research Centre (IN023)
Nashik, Maharashtra, 422005
Lata Mangeshkar Medical Foundation's (IN1001)
Pune, Maharashtra, 411004
Oyster and Pearl Hospital (IN1014)
Pune, Maharashtra, 411005
Nagecha Hospital, Creative Chamber (IN1015)
Rajkot, Gujarat, 360001
Divyam Clinic (IN1025)
Surat, Gujarat, 395001
GMERS Medical College and Hospital,Department of Psychiatry (IN1004)
Vadodara, Gujarat, 390021
Deva Institute of Healthcare and Research PVT ltd. (IN1005)
Varanasi, Uttar Pradesh, 221005
About this study
Official title: Open-label, Flexible-dose Study of Vortioxetine in Patients With Major Depressive Disorder in India
The purpose of this study is to evaluate the safety and tolerability of flexible doses of vortioxetine (5 - 20 mg/day) over a period of 12 weeks in patients with depression in India
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine
- 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.
VortioxetineDrug
5 - 20 mg/day flexible-dose vortioxetine, tablets, orally
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | flexible-dose Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-Emergent Adverse Events
Measured: From baseline to week 12
Secondary outcomes (3)
Change in Patient Health Questionnaire-9 (PHQ-9) total score
The PHQ-9 is a patient-rated scale designed to screen for and assess depression. The PHQ-9 consists of questions on each of the 9 DSM-5® criteria for depression asking if they have bothered the patient over the last 2 weeks. Each question is rated on a scale from 0 (not at all) to 3 (nearly every day). The 9 questions are summed to a total score ranging from 0 to 27 with higher scores reflecting greater severity.
Measured: From baseline to week 12
Change in Clinical Global Impression-severity of illness (CGI-S) score
The CGI was developed to provide global measures of the severity of a patient's clinical condition and improvement or worsening during clinical studies. 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 week 12
Clinical Global Impression-improvement (CGI-I)
The CGI was developed to provide global measures of the severity of a patient's clinical condition and improvement or worsening during clinical studies. 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).
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start20 Feb 2020
- Primary completion11 Feb 2022
- Study completion12 Mar 2022
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT04288895
- Sponsor's protocol ID
- 17775A
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adair M, Bose R, Schmidt SN. Safety and effectiveness of vortioxetine in patients with major depressive disorder in a real-life clinical setting in India: results from an interventional, flexible-dose study. Curr Med Res Opin. 2024 Sep;40(9):1637-1645. doi: 10.1080/03007995.2024.2382773. Epub 2024 Aug 7.
PubMed 39110846
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Flexible-dose Study of Vortioxetine in Patients With Major Depressive Disorder in India
- ClinicalTrials.gov ID
- NCT04288895
- Acronym / sponsor ID
- 17775A
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 28 Feb 2020 (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 safety and tolerability of flexible doses of vortioxetine (5 - 20 mg/day) over a period of 12 weeks in patients with depression in India
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: Vortioxetineflexible-dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has a Major Depressive Episode (MDE), is diagnosed with Major Depressive Disorder (MDD) according to DSM-5® and would benefit from pharmacological treatment with vortioxetine. The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a CGI-S ≥4 at screening.
Key exclusion criteria (3 listed)
- The patient has a significant risk of suicide according to investigator's clinical judgment or has made an actual suicide attempt in the period of 6 months prior to screening.
- The patient previously received vortioxetine.
- 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 |
|---|---|---|
| Vortioxetine5 - 20 mg/day flexible-dose vortioxetine, tablets, orally | Drug | Vortioxetine |
Primary outcome
Number of participants with Treatment-Emergent Adverse Events
Time frame: From baseline to week 12
3 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9) total score
Time frame: From baseline to week 12
Change in Clinical Global Impression-severity of illness (CGI-S) score
Time frame: From baseline to week 12
Clinical Global Impression-improvement (CGI-I)
Time frame: At week 12
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 18 Mar 2022.
- Derived from this study: PubMed 39110846Adair M, Bose R, Schmidt SN. Safety and effectiveness of vortioxetine in patients with major depressive disorder in a real-life clinical setting in India: results from an interventional, flexible-dose study. Curr Med Res Opin. 2024 Sep;40(9):1637-1645. doi: 10.1080/03007995.2024.2382773. Epub 2024 Aug 7.
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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
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 24 sites in India.
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 2 inclusion and 3 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in India. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of participants with Treatment-Emergent Adverse Events (time frame: From baseline to week 12). 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 NCT04288895, 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 18 Mar 2022.