MDDPhase 4RECONNECTNCT04220996
Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)
A Phase 4 study testing Vortioxetine in people with MDD and Anxiety Disorders, run by H. Lundbeck A/S at 21 sites in 6 countries.
Trial summary
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MDD, Anxiety Disorders
- 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
- 100 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 27 Dec 2019to 9 Mar 2021
- 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 primary diagnosis of MDE, diagnosed according to DSM-5® confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has had the current MDE for <12 months
- The patient has current comorbid Generalized Anxiety Disorder (GAD) according to DSM-5®. The diagnosis was made prior to the current MDE
- The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at the Baseline Visit
- The patient has a Hamilton Anxiety Rating Scale (HAM-A) score ≥ 20 at the Baseline Visit
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 International Neuropsychiatric Interview (MINI) or another diagnostic interview.
- The patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's opinion.
- Other in- or exclusion criteria may apply
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
Poland8 sites
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)
Bialystok, 15-404
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)
Bydgoszcz
CareClinic (PL0005)
Katowice
Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)
Kielce
Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)
Leszno
Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)
Lublin
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)
Poznan
Nzoz Syntonia (PL0010)
Pruszcz Gdański, 83-000
France4 sites
Cabinet du Docteur Patrick Bourgoin (FR0002)
Angoulême
Cabinet Psyche (FR0004)
Douai
Centre Medical Ambroise Pare (FR0003)
Élancourt
Cabinet du Docteur Karim Boutayeb (FR0001)
Viersat
South Korea3 sites
Inje University Ilsan Paik Hospital (KR0002)
Goyang-si
Chonnam National University Hospital (KR0003)
Gwangju
Samsung Medical Center (KR0001)
Seoul
Estonia2 sites
Marienthali Kliinik (EE0001)
Tallinn
Tartu University Hospital (EE0002)
Tartu
Italy2 sites
Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)
Perugia
Fondazione Santa Lucia IRCCS (IT0002)
Rome
Spain2 sites
Hospital Clinic de Barcelona (ES0003)
Barcelona
Instituto Internacional de Neurociencias Aplicadas (ES0001)
Barcelona
About this study
Official title: Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.
Read the detailed description
100 patients, recruited from psychiatrist outpatient clinics are planned for enrolment. Approximately 50 of these patients will receive vortioxetine as a first treatment for the current Major Depressive Episode (MDE) (first treatment patients) and 50 patients will be switched to vortioxetine due to inadequate response to the current antidepressant medication treatment (switch patients).
- Conditions
- MDD, Anxiety Disorders
- Being tested
- Vortioxetine
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Vortioxetine 10 and 20 mg/day, tablets, orally Patients will receive 10 mg vortioxetine once daily for the first week. At Visit 2, the dose will be increased to 20 mg/day. The dose may subsequently be adjusted to 10 or 20 mg/day at scheduled or unscheduled visits depending on patient's response as per investigator judgment.
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | 10-20 mg vortioxetine tablets Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
Measured: from baseline to Week 8
Secondary outcomes (6)
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 indicate very severe anxiety.
Measured: from baseline to Week 8
Change in Hospital Anxiety and Depression Scale (HADS) total score
The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21.
Measured: from baseline to Week 8
Change in Functioning Assessment Short Test (FAST) total score
The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. Each item is rated on a 4-point scale from 0 (no difficulty) to 3 (severe difficulty). The items are summed to yield a total score ranging from 0 to 72 with higher scores reflecting more serious difficulties.
Measured: from baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
The Clinical Global Impression severity of illness (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 8
Clinical Global Impression Scale- Global Improvement (CGI-I) score
The Clinical Global Impression - global improvement 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 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good).
Measured: from baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start27 Dec 2019
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
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 MDDStudies 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
- 100 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
- NCT04220996
- Sponsor's protocol ID
- 18314A
- Acronym
- RECONNECT
- Status last verified
- Apr 2021
- First submitted
- 6 Jan 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christensen MC, Schmidt S, Grande I. Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: Results of the RECONNECT study. J Psychopharmacol. 2022 May;36(5):566-577. doi: 10.1177/02698811221090627. Epub 2022 May 2.
PubMed 35499104
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT04220996
- Acronym / sponsor ID
- RECONNECT / 18314A
- Conditions
- MDD, Anxiety Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 7 Jan 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.
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.
Detailed description
100 patients, recruited from psychiatrist outpatient clinics are planned for enrolment. Approximately 50 of these patients will receive vortioxetine as a first treatment for the current Major Depressive Episode (MDE) (first treatment patients) and 50 patients will be switched to vortioxetine due to inadequate response to the current antidepressant medication treatment (switch patients).
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: Vortioxetine10-20 mg vortioxetine 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 a primary diagnosis of MDE, diagnosed according to DSM-5® confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has had the current MDE for <12 months
- The patient has current comorbid Generalized Anxiety Disorder (GAD) according to DSM-5®. The diagnosis was made prior to the current MDE
- The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at the Baseline Visit
- The patient has a Hamilton Anxiety Rating Scale (HAM-A) score ≥ 20 at the Baseline Visit
Key exclusion criteria (3 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 International Neuropsychiatric Interview (MINI) or another diagnostic interview.
- The patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's opinion.
- Other in- or 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 |
|---|---|---|
| VortioxetineVortioxetine 10 and 20 mg/day, tablets, orally Patients will receive 10 mg vortioxetine once daily for the first week. At Visit 2, the dose will be increased to 20 mg/day. The dose may subsequently be adjusted to 10 or 20 mg/day at scheduled or unscheduled visits depending on patient's response as per investigator judgment. | Drug | Vortioxetine |
Primary outcome
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
Time frame: from baseline to Week 8
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
6 secondary outcomes
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
Time frame: from baseline to Week 8
Change in Hospital Anxiety and Depression Scale (HADS) total score
Time frame: from baseline to Week 8
Change in Functioning Assessment Short Test (FAST) total score
Time frame: from baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
Time frame: from baseline to Week 8
Clinical Global Impression Scale- Global Improvement (CGI-I) score
Time frame: At Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
Time frame: from baseline to Week 8
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 20 Apr 2021.
- Derived from this study: PubMed 35499104Christensen MC, Schmidt S, Grande I. Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: Results of the RECONNECT study. J Psychopharmacol. 2022 May;36(5):566-577. doi: 10.1177/02698811221090627. Epub 2022 May 2.
- Individual participant dataSharing planned: Undecided
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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
21 sites in 6 countries: 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 MDD and Anxiety Disorders, run by H. Lundbeck A/S at 21 sites in 6 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 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Poland, France, South Korea, Estonia, Italy and 1 more country. 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?
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score (time frame: from baseline to Week 8). 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 NCT04220996, 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 20 Apr 2021.