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

NCT ID: NCT04220996

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-27
• Study Completion Date: 2021-03-09

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).

Conditions

MDD; Anxiety Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vortioxetine

10-20 mg vortioxetine tablets

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Marienthali Kliinik (EE0001)

Tallinn, , Estonia

Tartu University Hospital (EE0002)

Tartu, , Estonia

Cabinet du Docteur Patrick Bourgoin (FR0002)

Angoulême, , France

Cabinet Psyche (FR0004)

Douai, , France

Centre Medical Ambroise Pare (FR0003)

Élancourt, , France

Cabinet du Docteur Karim Boutayeb (FR0001)

Viersat, , France

Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)

Perugia, , Italy

Fondazione Santa Lucia IRCCS (IT0002)

Rome, , Italy

MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)

Bialystok, , Poland

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

Bydgoszcz, , Poland

CareClinic (PL0005)

Katowice, , Poland

Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)

Kielce, , Poland

Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)

Leszno, , Poland

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

Lublin, , Poland

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

Poznan, , Poland

Nzoz Syntonia (PL0010)

Pruszcz Gdański, , Poland

Inje University Ilsan Paik Hospital (KR0002)

Goyang-si, , South Korea

Chonnam National University Hospital (KR0003)

Gwangju, , South Korea

Samsung Medical Center (KR0001)

Seoul, , South Korea

Hospital Clinic de Barcelona (ES0003)

Barcelona, , Spain

Instituto Internacional de Neurociencias Aplicadas (ES0001)

Barcelona, , Spain

Countries

Estonia; France; Italy; Poland; South Korea; Spain

References

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.

Reference Type: DERIVED

PMID: 35499104 (View on PubMed)

Other Identifiers

18314A

Identifier Type: -

Identifier Source: org_study_id