THINC-it Vortioxetine - Sensitivity to Change

NCT03053362 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00020418
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Cognitive Change

Outcome Measures

Primary Outcomes (1)

• Cognition Measured Using the THINC-it Tool

  Change in cognition as measured by the objective assessments of cognition within the THINC-it tool. "THINC-it" is the name of the cognition tool and is not an acronym. The objective measurements that comprise the THINC-it tool include the Spotter task (Choice Reaction Time), Symbol Check task(1-back test),Trails task(Trails Making Test B), and Codebreaker task (Digit Symbol Substitution Test). The composite score from all four tests were converted to standard z-score. Higher z-scores indicate better cognition. A z-score of zero indicates population mean.

  Baseline and 8 weeks

Secondary Outcomes (6)

• Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS)

  Baseline and 8 weeks

• Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST)

  Baseline and 8 weeks

• Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B)

  Baseline and 8 weeks

• Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score

  Baseline and 8 weeks

• Changes in the World Health Organization Wellbeing Index (5-Item)

  Baseline and 8 weeks

Study Arms (2)

Major Depressive Disorder Population

EXPERIMENTAL

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; Other: THINC-it Tool

Healthy Control Population

OTHER

50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education

Other: THINC-it Tool

Interventions

Vortioxetine DRUG

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

Major Depressive Disorder Population

THINC-it Tool OTHER

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; Major Depressive Disorder Population

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is able and willing to provide informed consent.
• The participant is male or female 18-65 years of age.
• The participant has received a current diagnosis of a major depressive episode (MDE) as part of MDD as per DSM-5 criteria.
• The participant's current MDE is confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I 5.0.).
• The participant is an outpatient of a psychiatric setting.
• The participant has a MADRS score ≥ 26 at screening and baseline.
• The participant's reported duration of the current MDE is at least 3 months.
• At least one prior major depressive episode validated by previous treatment (e.g., guideline-informed pharmacotherapy and/or manual-based psychotherapy).
• 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.

You may not qualify if:

• Current alcohol and/or substance use disorder.
• 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.
• Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
• Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function (e.g., corticosteroids, beta-blockers).
• Use of benzodiazepines within 12 hours of cognitive assessments.
• Consumption of alcohol within 8 hours of cognitive assessments.
• Recent use of marijuana as determined by a toxicology screen.
• Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
• Diagnosis reading disability or dyslexia.
• Clinically significant learning disorder by history.
• Electroconvulsive therapy (ECT) in the last 6 months.
• 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.
• Pregnant and/or breastfeeding.
• Received investigational agents as part of a separate study within 30 days of the screening visit.
• 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).

Sponsors & Collaborators

• Brain and Cognition Discovery Foundation: lead

Study Sites (1)

CRTCE/KJK Healthplex

Toronto, Ontario, L5C 4E7, Canada

Location

Related Publications (3)

• McIntyre RS, Subramaniapillai M, Park C, Zuckerman H, Cao B, Lee Y, Iacobucci M, Nasri F, Fus D, Bowie CR, Tran T, Rosenblat JD, Mansur RB. The THINC-it Tool for Cognitive Assessment and Measurement in Major Depressive Disorder: Sensitivity to Change. Front Psychiatry. 2020 Jun 24;11:546. doi: 10.3389/fpsyt.2020.00546. eCollection 2020.

  PMID: 32670103 DERIVED

• Subramaniapillai M, Mansur RB, Zuckerman H, Park C, Lee Y, Iacobucci M, Cao B, Ho R, Lin K, Phan L, McIntyre RS. Association between cognitive function and performance on effort based decision making in patients with major depressive disorder treated with Vortioxetine. Compr Psychiatry. 2019 Oct;94:152113. doi: 10.1016/j.comppsych.2019.07.006. Epub 2019 Jul 24.

  PMID: 31404802 DERIVED

• Cao B, Park C, Subramaniapillai M, Lee Y, Iacobucci M, Mansur RB, Zuckerman H, Phan L, McIntyre RS. The Efficacy of Vortioxetine on Anhedonia in Patients With Major Depressive Disorder. Front Psychiatry. 2019 Jan 31;10:17. doi: 10.3389/fpsyt.2019.00017. eCollection 2019.

  PMID: 30766492 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Roger McIntyre
• Organization: Brain and Cognition Discovery Foundation

rogermcintyre28@gmail.com

(416) 943-6284

Study Officials

• Roger McIntyre

  Brain and Cognition Discovery Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Determining the effectiveness of a new tool used to detect changes in cognition among individuals with MDD.

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 15, 2017
• Study Start: May 24, 2017
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: June 8, 2025
• Results First Posted: January 20, 2022

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)