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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR TRINTELLIX

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Clinical Trials for Trintellix

Trial ID Title Status Sponsor Phase Summary
NCT02332954 Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine Active, not recruiting Lundbeck Canada Inc. Phase 4 The purpose of the study is to describe the association/correlation between change in patient-reported cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).
NCT02845349 Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI) Withdrawn Takeda Phase 3 Traumatic brain injury (TBI) is a major public health problem with an annual incidence of about 1.7 million per year. TBI is associated with various long-term morbidities. Among them, psychiatric disturbances are the major cause of chronic disability and poor quality of life. Major depression is the common psychiatric sequela post TBI with rates ranging from 13% at 1 year to 60% at 8 years after TBI. Major depression after TBI (henceforth referred to as TBI depression) is often associated with comorbid neuropsychiatric symptoms (NPS) such as anxiety, aggression, substance abuse and cognitive deficits that often makes treatment difficult. Despite increased rates of depression, there is no Food and Drug Administration (FDA) approved drug/s for its treatment. The investigators propose to address these limitations by use of a novel serotonergic agent, vortioxetine, which has a multimodal mechanism of action through serotonin transporter (SERT) inhibition, 5-hydroxytryptamine (5-HT)3, 7, and 1D receptor antagonism, 1B receptor partial agonism, and 1A receptor agonism. Overarching Goal: The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid NPS. Study Design: The study design will include a DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression. A total of 150 will be consented to allow for screen failures. Written informed consent will be obtained from these patients. Subjects will be followed for a total of 12 weeks. Subjects will be randomized to either the vortioxetine arm (N=15) or placebo arm (N=15). The treatment group will receive vortioxetine 10mg per day, which will be increased to 20 mg or decreased to 5 mg, if deemed clinically necessary, at week 4 or 8. Subjects will have a total of 4-5 visits: Baseline evaluation (1 or 2 visits) and follow-up visits at weeks 4, 8 and 12. Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline Relevance: This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities. If found to be effective, results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging.
NCT02845349 Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI) Withdrawn Johns Hopkins University Phase 3 Traumatic brain injury (TBI) is a major public health problem with an annual incidence of about 1.7 million per year. TBI is associated with various long-term morbidities. Among them, psychiatric disturbances are the major cause of chronic disability and poor quality of life. Major depression is the common psychiatric sequela post TBI with rates ranging from 13% at 1 year to 60% at 8 years after TBI. Major depression after TBI (henceforth referred to as TBI depression) is often associated with comorbid neuropsychiatric symptoms (NPS) such as anxiety, aggression, substance abuse and cognitive deficits that often makes treatment difficult. Despite increased rates of depression, there is no Food and Drug Administration (FDA) approved drug/s for its treatment. The investigators propose to address these limitations by use of a novel serotonergic agent, vortioxetine, which has a multimodal mechanism of action through serotonin transporter (SERT) inhibition, 5-hydroxytryptamine (5-HT)3, 7, and 1D receptor antagonism, 1B receptor partial agonism, and 1A receptor agonism. Overarching Goal: The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid NPS. Study Design: The study design will include a DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression. A total of 150 will be consented to allow for screen failures. Written informed consent will be obtained from these patients. Subjects will be followed for a total of 12 weeks. Subjects will be randomized to either the vortioxetine arm (N=15) or placebo arm (N=15). The treatment group will receive vortioxetine 10mg per day, which will be increased to 20 mg or decreased to 5 mg, if deemed clinically necessary, at week 4 or 8. Subjects will have a total of 4-5 visits: Baseline evaluation (1 or 2 visits) and follow-up visits at weeks 4, 8 and 12. Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline Relevance: This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities. If found to be effective, results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging.
NCT02969876 Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine Recruiting Takeda Phase 4 The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.
NCT02969876 Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine Recruiting Massachusetts General Hospital Phase 4 The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Trintellix

Condition Name

Condition Name for Trintellix
Intervention Trials
Major Depressive Disorder 3
Major Depression 2
Depression 1
Type2 Diabetes 1
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Condition MeSH

Condition MeSH for Trintellix
Intervention Trials
Depressive Disorder, Major 5
Depressive Disorder 5
Depression 5
Neurobehavioral Manifestations 1
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Clinical Trial Locations for Trintellix

Trials by Country

Trials by Country for Trintellix
Location Trials
Canada 8
United States 3
Ukraine 1
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Trials by US State

Trials by US State for Trintellix
Location Trials
Illinois 1
Missouri 1
Massachusetts 1
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Clinical Trial Progress for Trintellix

Clinical Trial Phase

Clinical Trial Phase for Trintellix
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Trintellix
Clinical Trial Phase Trials
Active, not recruiting 2
Recruiting 2
Withdrawn 1
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Clinical Trial Sponsors for Trintellix

Sponsor Name

Sponsor Name for Trintellix
Sponsor Trials
Takeda 4
Massachusetts General Hospital 1
Johns Hopkins University 1
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Sponsor Type

Sponsor Type for Trintellix
Sponsor Trials
Other 6
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Fuji
Argus Health
Harvard Business School
McKinsey
Moodys
Johnson and Johnson
Covington

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