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Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD) (RECONNECT)

Primary Purpose

MDD, Anxiety Disorders

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vortioxetine
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MDD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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 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

Sites / Locations

  • Marienthali Kliinik (EE0001)
  • Tartu University Hospital (EE0002)
  • Cabinet du Docteur Patrick Bourgoin (FR0002)
  • Cabinet Psyche (FR0004)
  • Cabinet du Docteur Karim Boutayeb (FR0001)
  • Centre Medical Ambroise Pare (FR0003)
  • Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)
  • Fondazione Santa Lucia IRCCS (IT0002)
  • Inje University Ilsan Paik Hospital (KR0002)
  • Chonnam National University Hospital (KR0003)
  • Samsung Medical Center (KR0001)
  • MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)
  • NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)
  • CareClinic (PL0005)
  • Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)
  • Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)
  • Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)
  • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)
  • Nzoz Syntonia (PL0010)
  • Hospital Clinic de Barcelona (ES0003)
  • Instituto Internacional de Neurociencias Aplicadas (ES0001)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vortioxetine

Arm Description

10-20 mg vortioxetine tablets

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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).
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).

Full Information

First Posted
January 6, 2020
Last Updated
April 19, 2021
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04220996
Brief Title
Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)
Acronym
RECONNECT
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDD, Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Experimental
Arm Description
10-20 mg vortioxetine tablets
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
Description
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.
Time Frame
from baseline to Week 8
Secondary Outcome Measure Information:
Title
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
Description
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.
Time Frame
from baseline to Week 8
Title
Change in Hospital Anxiety and Depression Scale (HADS) total score
Description
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.
Time Frame
from baseline to Week 8
Title
Change in Functioning Assessment Short Test (FAST) total score
Description
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.
Time Frame
from baseline to Week 8
Title
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
Description
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).
Time Frame
from baseline to Week 8
Title
Clinical Global Impression Scale- Global Improvement (CGI-I) score
Description
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).
Time Frame
At Week 8
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
Description
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).
Time Frame
from baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Marienthali Kliinik (EE0001)
City
Tallinn
Country
Estonia
Facility Name
Tartu University Hospital (EE0002)
City
Tartu
Country
Estonia
Facility Name
Cabinet du Docteur Patrick Bourgoin (FR0002)
City
Angoulême
Country
France
Facility Name
Cabinet Psyche (FR0004)
City
Douai
Country
France
Facility Name
Cabinet du Docteur Karim Boutayeb (FR0001)
City
Viersat
Country
France
Facility Name
Centre Medical Ambroise Pare (FR0003)
City
Élancourt
Country
France
Facility Name
Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)
City
Perugia
Country
Italy
Facility Name
Fondazione Santa Lucia IRCCS (IT0002)
City
Rome
Country
Italy
Facility Name
Inje University Ilsan Paik Hospital (KR0002)
City
Goyang-si
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital (KR0003)
City
Gwangju
Country
Korea, Republic of
Facility Name
Samsung Medical Center (KR0001)
City
Seoul
Country
Korea, Republic of
Facility Name
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)
City
Białystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)
City
Bydgoszcz
Country
Poland
Facility Name
CareClinic (PL0005)
City
Katowice
Country
Poland
Facility Name
Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)
City
Kielce
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)
City
Leszno
Country
Poland
Facility Name
Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)
City
Lublin
Country
Poland
Facility Name
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)
City
Poznan
Country
Poland
Facility Name
Nzoz Syntonia (PL0010)
City
Pruszcz Gdański
ZIP/Postal Code
83-000
Country
Poland
Facility Name
Hospital Clinic de Barcelona (ES0003)
City
Barcelona
Country
Spain
Facility Name
Instituto Internacional de Neurociencias Aplicadas (ES0001)
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35499104
Citation
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.
Results Reference
derived

Learn more about this trial

Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)

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