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THINC-it Vortioxetine - Sensitivity to Change

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ClinicalTrials.gov Identifier: NCT03053362
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Brain and Cognition Discovery Foundation

Brief Summary:

The purpose of this study is to evaluate the sensitivity of the THINC-it tool, in measuring change in cognitive deficits in individuals with MDD after receiving vortioxetine.

Vortioxetine is used in this study as an antidepressant to improve mood, cognition and quality of life. "Cognition" refers to intellectual functions such as thinking, understanding, learning and remembering. Vortioxetine is approved by Health Canada for the treatment of MDD. In addition, vortioxetine has been reported to have a beneficial effect on cognitive areas such as executive function, attention/speed of processing, and memory, that are commonly affected negatively by MDD. Vortioxetine is recognized by Health Authorities in the EU and many other countries as having a benefit on cognitive dysfunction (loss of intellectual functions) in patients with MDD.Cognitive dysfunction is a highly persistent, pervasive and progressive abnormality in young adults (i.e., 18-65 years) with MDD.

It has also been shown that among adults with MDD who are gainfully employed, measures of cognition are a greater determinant of overall workplace performance than is total depression symptom severity. Several lines of evidence indicate that cognitive deficits that persist between episodes of depression are critical determinants of functional recovery in the workplace. The functional implications associated with cognitive impairment provide the impetus for systematic evaluation, measurement and assessment of the domains of cognition expected to be impaired in this patient population.

To date, no measurement tool has been sufficiently validated and/or determined to be sensitive to the cognitive deficits in younger adults with MDD. Major limitations of available comprehensive psychometric tools include relative lack of availability, cost, lack of access to most healthcare providers, and above all else, the lengthy time to administer. Moreover, the need for a psychometrist to interpret the results adds to the complexity and the costliness of such an endeavor.

It is imperative that any tool recommended for clinical utility be aligned with the busy nature of a high-volume clinical practice. The ideal gold standard tool for assessing the presence of cognitive dysfunction in MDD in the clinical environment should include, but not be limited to, features such as good conceptual coverage of cognitive domains affected in MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture effects and practice effects. The tool would also need to be brief, easy to administer and interpret, and complement busy clinical practice.

It is anticipated that the THINC-it tool will be free of charge and downloadable from the THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be accessible via computers/tablets, will take 20 minutes to self-administer in a clinical setting, and the performance results will be immediately available.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Cognitive Change Drug: Vortioxetine Other: THINC-it Tool Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Determining the effectiveness of a new tool used to detect changes in cognition among individuals with MDD.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label Clinical Trial Evaluating Sensitivity to Change in Cognition Using the THINC-it Following Treatment With Vortioxetine in Major Depressive Disorder
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Major Depressive Disorder Population

100 Individuals with DSM-5-defined MDD, aged 18-65

All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.

Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.

Drug: Vortioxetine
Observing change in cognition using THINC-it tool in patients with MDD.

Other: THINC-it Tool

Digitalized cognitive test application administering the following cognitive test components:

Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)


Healthy Control Population
50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education
Other: THINC-it Tool

Digitalized cognitive test application administering the following cognitive test components:

Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)





Primary Outcome Measures :
  1. Cognition measured using the THINC-it tool [ Time Frame: 8 weeks ]
    To establish sensitivity to change in cognitive function/performance using THINC-it tool in adults (18-65) with MDD treated with vortioxetine (10-20 mg flexibly dosed for 8 weeks).


Secondary Outcome Measures :
  1. Early changes in mood as measured by the Montgomery Åsberg Depression Rating Scale [ Time Frame: 2 weeks ]
    Determining whether early changes (i.e., Day 14; Week 2) in cognitive function/performance, predict symptomatic improvements in mood (defined as a reduction of 50% or more on total mood score [as measured by the Montgomery Åsberg Depression Rating Scale [MADRS]. The overall score ranges from 0 to 60. The questionnaire includes questions to measure the severity of depressive symptoms in patients with mood disorders.

  2. Early changes in cognition using Sheehan Disability Scale [ Time Frame: 2 weeks ]
    Sheehan Disability Scale rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The numerical ratings of 0-10 can be translated into a percentage if desired. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

  3. Early changes in cognition using Endicott Work Productivity Scale [ Time Frame: 2 weeks ]
    The Endicott Work Productivity Scale (EWPS) is a a brief (25-item) selfreport questionnaire designed to assess the degree to which a medical condition, such as a depressive disorder, affects the work functioning of a subject. The individual items of the scale have face validity as measures of different ways that work activities may be altered so that productivity and efficiency are reduced. The total score is a sensitive measure that will (1) discriminate among subjects who have varying degrees of difficulty in accomplishing their work due to an illness (rather than lack of training, skills, or aptitude) and (2) reflect even small changes in behavior related to work productivity. The items are rated on a 5-point scale of how often the behavior or feeling, or attitude has been manifested during the past week. he total score ranges from 0 (best possible score) to 100 (for the worst possible score).

  4. Early changes in cognition using the 5-Item World Health Organization Wellbeing Index [ Time Frame: 2 weeks ]
    The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive questions, which tap into the subjective well-being of the respondents. The WHO-5 only contains positively phrased items. The respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

MDD Population

Inclusion Criteria:

  1. The participant is able and willing to provide informed consent.
  2. The participant is male or female 18-65 years of age.
  3. The participant has received a current diagnosis of a major depressive episode (MDE) as part of MDD as per DSM-5 criteria.
  4. The participant's current MDE is confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I 5.0.).
  5. The participant is an outpatient of a psychiatric setting.
  6. The participant has a MADRS score ≥ 26 at screening and baseline.
  7. The participant's reported duration of the current MDE is at least 3 months.
  8. At least one prior major depressive episode validated by previous treatment (e.g., guideline-informed pharmacotherapy and/or manual-based psychotherapy).
  9. All participants will be screened for cognitive impairment based on DSST performance (pen-and-paper version) with a maximum baseline score of 70 correct symbols entered to avoid ceiling effects.

Exclusion Criteria:

  1. Current alcohol and/or substance use disorder.
  2. Presence of comorbid psychiatric disorder other than MDD that is a focus of clinical concern as confirmed by the M.I.N.I 5.0.
  3. Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
  4. Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function (e.g., corticosteroids, beta-blockers).
  5. Use of benzodiazepines within 12 hours of cognitive assessments.
  6. Consumption of alcohol within 8 hours of cognitive assessments.
  7. Recent use of marijuana as determined by a toxicology screen.
  8. Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
  9. Diagnosis reading disability or dyslexia.
  10. Clinically significant learning disorder by history.
  11. Electroconvulsive therapy (ECT) in the last 6 months.
  12. History of moderate or severe head trauma (e.g., loss of consciousness for >1 hour), other neurological disorders, or unstable systemic medical diseases that in the opinion of the investigator are likely to affect the central nervous system.
  13. Pregnant and/or breastfeeding.
  14. Received investigational agents as part of a separate study within 30 days of the screening visit.
  15. Actively suicidal or evaluated as being a suicide risk (a score of > 4 on the MADRS and/or per clinical judgment using the Columbia-Suicide Severity Rating Scale).
  16. Currently receiving treatment with Monoamine Oxidase Inhibitors (MAOIs) anti-depressants, antibiotics such as linezolid, or intravenous methylene blue.

Healthy Control Population

Inclusion Criteria:

  1. No current or past history of mental disorder as evidenced by the M.I.N.I. 5.0 for DSM-IV.
  2. No first-degree relative with an established diagnosis by a healthcare provider of a mood or psychiatric disorder.
  3. No unstable medical disorders.

Exclusion Criteria:

  1. Use of any medication for a general medical disorder and/or condition that, in the opinion of the investigator, may affect cognitive function (e.g., corticosteroids, beta-blockers).
  2. Pregnant and/or breastfeeding.
  3. Consumption of alcohol within 8 hours of THINC-it tool administration.
  4. Recent use of marijuana as determined by a toxicology screen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053362


Locations
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Canada, Ontario
Toronto Sleep Clinic
Toronto, Ontario, Canada
Sponsors and Collaborators
Brain and Cognition Discovery Foundation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brain and Cognition Discovery Foundation
ClinicalTrials.gov Identifier: NCT03053362     History of Changes
Other Study ID Numbers: Pro00020418
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists