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

NCT04220996 | Completed Phase 4

• 1 other identifier: 18314A
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 19

Brief Summary

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

Conditions

MDD; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  from baseline to Week 8

Secondary Outcomes (6)

• Change in Hamilton Anxiety Rating Scale (HAM-A) total score

  from baseline to Week 8

• Change in Hospital Anxiety and Depression Scale (HADS) total score

  from baseline to Week 8

• Change in Functioning Assessment Short Test (FAST) total score

  from baseline to Week 8

• Change in Clinical Global Impression - Severity of Illness (CGI-S) score

  from baseline to Week 8

• Clinical Global Impression Scale- Global Improvement (CGI-I) score

  At Week 8

Study Arms (1)

Vortioxetine

EXPERIMENTAL

10-20 mg vortioxetine tablets

Drug: Vortioxetine

Interventions

Vortioxetine 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.

Vortioxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (21)

Marienthali Kliinik (EE0001)

Tallinn, Estonia

Location

Tartu University Hospital (EE0002)

Tartu, Estonia

Location

Cabinet du Docteur Patrick Bourgoin (FR0002)

Angoulême, France

Location

Cabinet Psyche (FR0004)

Douai, France

Location

Centre Medical Ambroise Pare (FR0003)

Élancourt, France

Location

Cabinet du Docteur Karim Boutayeb (FR0001)

Viersat, France

Location

Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)

Perugia, Italy

Location

Fondazione Santa Lucia IRCCS (IT0002)

Rome, Italy

Location

MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)

Bialystok, 15-404, Poland

Location

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

Bydgoszcz, Poland

Location

CareClinic (PL0005)

Katowice, Poland

Location

Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)

Kielce, Poland

Location

Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)

Leszno, Poland

Location

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

Lublin, Poland

Location

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

Poznan, Poland

Location

Nzoz Syntonia (PL0010)

Pruszcz Gdański, 83-000, Poland

Location

Inje University Ilsan Paik Hospital (KR0002)

Goyang-si, South Korea

Location

Chonnam National University Hospital (KR0003)

Gwangju, South Korea

Location

Samsung Medical Center (KR0001)

Seoul, South Korea

Location

Hospital Clinic de Barcelona (ES0003)

Barcelona, Spain

Location

Instituto Internacional de Neurociencias Aplicadas (ES0001)

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 35499104 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 7, 2020
• Study Start: December 27, 2019
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

KR (3); ES (2); IT (2); FR (4); PL (8)