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

April 19, 2021 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia
        • Marienthali Kliinik (EE0001)
      • Tartu, Estonia
        • Tartu University Hospital (EE0002)
  • France
      • Angoulême, France
        • Cabinet du Docteur Patrick Bourgoin (FR0002)
      • Douai, France
        • Cabinet Psyche (FR0004)
      • Viersat, France
        • Cabinet du Docteur Karim Boutayeb (FR0001)
      • Élancourt, France
        • Centre Medical Ambroise Pare (FR0003)
  • Italy
      • Perugia, Italy
        • Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)
      • Rome, Italy
        • Fondazione Santa Lucia IRCCS (IT0002)
  • Korea, Republic of
      • Goyang-si, Korea, Republic of
        • Inje University Ilsan Paik Hospital (KR0002)
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital (KR0003)
      • Seoul, Korea, Republic of
        • Samsung Medical Center (KR0001)
  • Poland
      • Białystok, Poland, 15-404
        • MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)
      • Bydgoszcz, Poland
        • NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)
      • Katowice, Poland
        • CareClinic (PL0005)
      • Kielce, Poland
        • Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)
      • Leszno, Poland
        • Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)
      • Lublin, Poland
        • Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)
      • Poznan, Poland
        • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)
      • Pruszcz Gdański, Poland, 83-000
        • Nzoz Syntonia (PL0010)
  • Spain
      • Barcelona, Spain
        • Hospital Clinic de Barcelona (ES0003)
      • Barcelona, Spain
        • Instituto Internacional de Neurociencias Aplicadas (ES0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vortioxetine
10-20 mg vortioxetine tablets
Drug: Vortioxetine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
Time Frame: from baseline to Week 8
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.
from baseline to Week 8
Change in Hospital Anxiety and Depression Scale (HADS) total score
Time Frame: from baseline to Week 8
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.
from baseline to Week 8
Change in Functioning Assessment Short Test (FAST) total score
Time Frame: from baseline to Week 8
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.
from baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
Time Frame: from baseline to Week 8
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).
from baseline to Week 8
Clinical Global Impression Scale- Global Improvement (CGI-I) score
Time Frame: At Week 8
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).
At Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
Time Frame: from baseline to Week 8
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).
from baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2019

Primary Completion (Actual)

March 9, 2021

Study Completion (Actual)

March 9, 2021

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18314A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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