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

Last updated: April 19, 2021
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

4

Condition

Panic Disorders

Anxiety Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT04220996
18314A
  • Ages 18-65
  • All Genders

Study Summary

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient has a primary diagnosis of MDE, diagnosed according to DSM-5® confirmedusing 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 toDSM-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 BaselineVisit

Exclusion

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 MiniInternational Neuropsychiatric Interview (MINI) or another diagnostic interview.
  • The patient has a history of previous major depressive episodes considered astreatment resistant, defined as inadequate response (incomplete or no therapeuticresponse) to two prior courses of at least 6 weeks of conventional antidepressantdrugs in adequate dosages or, the patient has treatment-resistant depression in theinvestigator's opinion. Other in- or exclusion criteria may apply

Study Design

Total Participants: 100
Study Start date:
December 27, 2019
Estimated Completion Date:
March 09, 2021

Study 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).

Connect with a study center

  • Marienthali Kliinik (EE0001)

    Tallinn,
    Estonia

    Site Not Available

  • Tartu University Hospital (EE0002)

    Tartu,
    Estonia

    Site Not Available

  • Cabinet du Docteur Patrick Bourgoin (FR0002)

    Angoulême,
    France

    Site Not Available

  • Cabinet Psyche (FR0004)

    Douai,
    France

    Site Not Available

  • C.P.P. Ile de France V Hôpital Saint-Antoine (FR001)

    Paris, 75571
    France

    Site Not Available

  • Cabinet du Docteur Karim Boutayeb (FR0001)

    Viersat,
    France

    Site Not Available

  • Centre Medical Ambroise Pare (FR0003)

    Élancourt,
    France

    Site Not Available

  • Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)

    Perugia,
    Italy

    Site Not Available

  • Fondazione Santa Lucia IRCCS (IT0002)

    Rome,
    Italy

    Site Not Available

  • Inje University Ilsan Paik Hospital (KR0002)

    Goyang-si,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital (KR0003)

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center (KR0001)

    Seoul,
    Korea, Republic of

    Site Not Available

  • MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)

    Białystok, 15-404
    Poland

    Site Not Available

  • NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)

    Bydgoszcz,
    Poland

    Site Not Available

  • CareClinic (PL0005)

    Katowice,
    Poland

    Site Not Available

  • Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)

    Kielce,
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)

    Leszno,
    Poland

    Site Not Available

  • Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)

    Lublin,
    Poland

    Site Not Available

  • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)

    Poznan,
    Poland

    Site Not Available

  • Nzoz Syntonia (PL0010)

    Pruszcz Gdański, 83-000
    Poland

    Site Not Available

  • Hospital Clinic de Barcelona (ES0003)

    Barcelona,
    Spain

    Site Not Available

  • Instituto Internacional de Neurociencias Aplicadas (ES0001)

    Barcelona,
    Spain

    Site Not Available

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