Validation Study: Mobile DSST on Cognition in Adults With MDD

NCT03999567 | Completed DMC

• 1 other identifier: Pro00037042
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives The primary objective of this study is to determine the convergent validity of the mobile DSST application with the pencil and paper version of the DSST. Design and Outcomes This study will be performed by the Brain and Cognition Discovery Foundation (BCDF). The BCDF is an organization based in Toronto, Ontario, Canada led by Dr. Roger S. McIntyre. Membership of the BCDF has developed and validated rating scales and metrics for adults with mood disorders for over 10 years. A member of the BCDF provides diagnoses and treatment for adults (age 18-65) with mood disorders and provides clinical care to the largest catchment area in Canada. The BCDF conducts clinical research according to the International Conference on Harmonization, Declaration of Helsinki, and Good Clinical Practice (GCP) guidelines. The study will be approved by the community Research Ethics Board. Thirty adults (18-65) with DSM-5 MDD will be enrolled at the BCDF Toronto, Ontario. All subjects will have their diagnosis ascertained clinically and confirmed by Mini International Neuropsychiatric Interview Version 5.0 (M.I.N.I.). At baseline, data will be collected from all participants and will include demographics, comorbidities, medication history and concurrent medications. All subjects will be assessed symptomatically with the Montgomery and Asberg Depression Rating Scale (MADRS) as well as the Hamilton Anxiety Rating Scale (HAM-A), Snaith Hamilton Pleasure Scale (SHAPS) for anhedonia, as well as the paper and pencil version of the DSST at baseline and end of study (Day 7). The DSST has been normed on the sex, age and gender. These norms will be used as reference. All subjects will complete the pencil and paper version of the DSST and complete the mobile app-based version of the DSST. Sample Size and Population This is a small validation study of 30 subjects. Subjects diagnosed with major depressive disorder will be eligible for participation in this study.

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

• Validation of the mobile DSST application

  The primary objective of this study is to determine the convergent validity of the mobile DSST application with the pencil version of the DSST. Correlation between performance on the digitalized DSST and the pencil and paper version will be conducted. In light of the small sample size and this being a feasibility pilot study, we will be looking at descriptive statistics of demographics, depression severity and cognition performance. An interim analysis will be completed after the first 15 subjects complete the study.

  1 week

Secondary Outcomes (3)

• Montgomery and Asberg Depression Rating Scale (MADRS)

  1 week

• Hamilton Anxiety Rating Scale (HAM-A)

  1 week

• Snaith Hamilton Pleasure Scale (SHAPS )

  1 week

Study Arms (1)

Pen and Paper vs. Mobile Digit Symbol Substitution Test

EXPERIMENTAL

This validation study will assess the convergent validity of the mobile DSST application with the pencil version of the DSST. Correlations between performance on app-based version of the DSST and paper-based version of DSST will be measured.

Other: Pen and Paper Digit Symbol Substitution Test (DSST); Other: Electronic Digit Symbol Substitution Test (DSST)- (a.k.a. Codebreaker)

Interventions

Pen and Paper Digit Symbol Substitution Test (DSST) OTHER

The DSST is a paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located on the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90 to 120 seconds, constitutes the score.

Pen and Paper vs. Mobile Digit Symbol Substitution Test

Electronic Digit Symbol Substitution Test (DSST)- (a.k.a. Codebreaker) OTHER

Code breaker is the mobile/electronic version of the pen and paper DSST which is capable of identifying deficits in the domains of executive function, processing speed and attention/concentration, and takes 2 minutes to complete. Six symbols are numbered consecutively. Users are presented with a series of numbers that they must then match with the correct corresponding symbol as quickly as possible. Users are scored on speed and accuracy.

Pen and Paper vs. Mobile Digit Symbol Substitution Test

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 participant is able and willing to provide informed consent.
• The participant is male or female 18-65 years of age and owns a smart phone.
• 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 M.I.N.I.
• The participant is an outpatient of a psychiatric setting.
• The participant has a MADRS score ≥ 20 at screening and baseline.
• At least one prior MDE formally diagnosed by a healthcare provider or validated by previous treatment (e.g., guideline-informed pharmacotherapy and/or manual-based psychotherapy).

You may not qualify if:

• Current alcohol and/or substance use disorder as confirmed by the M.I.N.I.
• Presence of comorbid psychiatric disorder other than MDD that is a focus of clinical concern as confirmed by the M.I.N.I.
• 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.
• Use of benzodiazepines within 12 hours of cognitive assessments.
• Consumption of alcohol within 8 hours of cognitive assessments.
• Inconsistent use or abuse of marijuana.
• Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
• Diagnosed 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/presence of suicidal ideation or evaluated as being a suicide risk (as per clinical judgment using the Columbia-Suicide Severity Rating Scale).

Sponsors & Collaborators

• Brain and Cognition Discovery Foundation: lead
• Takeda: collaborator
• Cognition Kit: collaborator
• Ctrl Group, Ltd: collaborator

Study Sites (1)

Canadian Rapid Treatment Centre of Excellence

Mississauga, Ontario, L5C 4E7, Canada

Location

Related Publications (1)

• McIntyre RS, Lipsitz O, Rodrigues NB, Subramaniapillai M, Nasri F, Lee Y, Fehnert B, King J, Chrones L, Kratiuk K, Uddin S, Rosenblat JD, Mansur RB, McCue M. An App-Based Digit Symbol Substitution Test for Assessment of Cognitive Deficits in Adults With Major Depressive Disorder: Evaluation Study. JMIR Ment Health. 2022 Oct 27;9(10):e33871. doi: 10.2196/33871.

  PMID: 36301615 DERIVED

MeSH Terms

Interventions

penclomedine

Study Officials

• Roger McIntyre, MD

  Brain and Cognition Discovery Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Executive Director

Model Details: Thirty adults (18-65) with DSM-5 MDD will be enrolled at the BCDF Toronto, Ontario. All subjects will have their diagnosis confirmed by Mini International Neuropsychiatric Interview Version 6.0. At baseline, data will be collected from all participants and will include demographics, comorbidities, medication history and concurrent medications. All subjects will be assessed symptomatically with the Montgomery and Asberg Depression Rating Scale (MADRS) as well as the Hamilton Anxiety Rating Scale (HAM-A), Snaith Hamilton Pleasure Scale (SHAPS) for anhedonia, as well as the paper and pencil version of the DSST at baseline and end of study (Day 7). The DSST has been normed on the sex, age and gender. These norms will be used as reference. All subjects will complete the pencil and paper version of the DSST and complete the mobile app-based version of the DSST.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 26, 2019
• Study Start: August 25, 2019
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

CA (1)