Clinical trial NCT04220996: Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: MDD
Anxiety Disorders
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
timeFrame: from baseline to Week 8
Secondary outcomes:
measure: Change in Hamilton Anxiety Rating Scale (HAM-A) total score
timeFrame: from baseline to Week 8
measure: Change in Hospital Anxiety and Depression Scale (HADS) total score
timeFrame: from baseline to Week 8
measure: Change in Functioning Assessment Short Test (FAST) total score
timeFrame: from baseline to Week 8
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S) score
timeFrame: from baseline to Week 8
measure: Clinical Global Impression Scale- Global Improvement (CGI-I) score
timeFrame: At Week 8
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
timeFrame: from baseline to Week 8
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Marienthali Kliinik (EE0001)
city: Tartu
country: Estonia
facility: Tartu University Hospital (EE0002)
city: Angoulême
country: France
facility: Cabinet du Docteur Patrick Bourgoin (FR0002)
city: Douai
country: France
facility: Cabinet Psyche (FR0004)
city: Viersat
country: France
facility: Cabinet du Docteur Karim Boutayeb (FR0001)
city: Élancourt
country: France
facility: Centre Medical Ambroise Pare (FR0003)
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)
city: Rome
country: Italy
facility: Fondazione Santa Lucia IRCCS (IT0002)
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital (KR0002)
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital (KR0003)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center (KR0001)
city: Białystok
country: Poland
facility: MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)
city: Bydgoszcz
country: Poland
facility: NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)
city: Katowice
country: Poland
facility: CareClinic (PL0005)
city: Kielce
country: Poland
facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)
city: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)
city: Lublin
country: Poland
facility: Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)
city: Poznan
country: Poland
facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)
city: Pruszcz Gdański
country: Poland
facility: Nzoz Syntonia (PL0010)
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (ES0003)
city: Barcelona
country: Spain
facility: Instituto Internacional de Neurociencias Aplicadas (ES0001)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
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.