Clinical trial NCT02972632: Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
Official title: An Open-Label, Single-Arm, Multicenter, Prospective, Phase 4, Interventional, Flexible Dose Study to Evaluate the Effectiveness of Vortioxetine on Goal Achievement After a Change in Antidepressant Medication for the Treatment of Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-11-23
Enrollment: 123
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: The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).

Detailed description: The drug being tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in people who have major depressive disorder. This study will look at effectiveness of treatment with vortioxetine in participant's goal achievement for the treatment of major depressive disorder.

The study enrolled 123 patients. Participants will receive:

• Vortioxetine 10 to 20 mg

All participants will be asked to take one tablet at the same time each day throughout the study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to 20 mg. The dose may then be decreased by 5 mg based on participant's response and tolerability to higher dose as judged by the Investigator.

This multi-center trial will be conducted in Unites States. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

1. Is suffering from Major Depressive Disorder (MDD) as the primary psychiatric diagnosis.
2. Has been or is currently being treated with an approved antidepressant (monotherapy) for 6 weeks or longer at an adequate therapeutic dose. Participants currently on an antidepressant at Screening will be discontinued in a manner that is consistent with labeling recommendations and conventional medical practice.
3. The antidepressant treatment must be on-going at time of Screening or have been discontinued within the 6 weeks prior to Screening.
4. Is considered appropriate for a change in antidepressant medication based on Investigator judgment in collaboration with the participant.
5. Has scores on Patient Health Questionnaire (PHQ-9) ≥5 and Clinical Global Impression Scale Severity (CGI-S ≥4).

Exclusion Criteria:

1. Has discontinued prior antidepressant treatment greater than 6 weeks from Screening.
2. Is considered to be at imminent risk for hospitalization due to severe depression in the opinion of the investigator. Recent hospitalization due to MDD within 3 months prior to Screening is exclusionary also.
3. Has a significant risk of suicide according to the Investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening or scores "yes" on items 4 or 5 in the past 6 months on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS).
4. Is considered to be treatment resistant, defined as participants with MDD who have not responded to 2 or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in their current episode. History of only responding to combination or augmentation therapy in previous major depressive episode (MDEs) is also considered evidence of treatment resistant depression.
5. Has 1 or more of the following:

   1. Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as determined by the investigator.
   2. Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine). The participants must have a negative urine drug screen (UDS) at Screening and Baseline, this includes benzodiazepines and opiates (including oxycodone) for which there is no prescription.
   3. Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
   4. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
6. Has a known history of acute narrow-angle glaucoma or is at risk of acute narrow-angle glaucoma.
7. Has a known unstable thyroid disorder or a thyroid-stimulating hormone value outside the normal range based on medical history that is deemed clinically significant by the investigator.
8. Has active hepatitis B or a known history of hepatitis C virus.
9. Has a known history of human immunodeficiency virus infection.
10. Has a history of gastric bypass.
11. Has previously or is currently participating in this study or another vortioxetine or LuAA21004 study.
12. Is receiving or who have started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plan to initiate such therapy during the study.

Primary outcomes:
measure: Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12
timeFrame: Baseline and Weeks 6 and 12
measure: Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12
timeFrame: Baseline and Weeks 6 and 12
measure: Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12
timeFrame: Baseline and Weeks 6 and 12
measure: Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12
timeFrame: Baseline and Week 12
measure: Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Upland
country: United States
facility: University Medical Group
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Inc.
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research , Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research Main
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: New Bedford
country: United States
facility: Novex Clinical Research, LLC
state: Massachusetts
city: South Weymouth
country: United States
facility: Coastal Research Associates, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Ann Arbor
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Lansdale
country: United States
facility: Green & Seidner Family Practice Associates
state: Pennsylvania
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands
state: Texas
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References:
citation: McCue M, Sarkey S, Eramo A, Francois C, Parikh SV. Using the Goal Attainment Scale adapted for depression to better understand treatment outcomes in patients with major depressive disorder switching to vortioxetine: a phase 4, single-arm, open-label, multicenter study. BMC Psychiatry. 2021 Dec 11;21(1):622. doi: 10.1186/s12888-021-03608-1.