Major Depressive Episode Clinical Trial
Official title:
A Validation Study of a Mobile Phone Digit Symbol Substitution Test Application for Cognition in Adults With Major Depressive Disorder
Verified date | July 2020 |
Source | Brain and Cognition Discovery Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 4, 2020 |
Est. primary completion date | February 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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). - Currently receiving treatment with Monoamine Oxidase Inhibitors anti-depressants, antibiotics such as linezolid, or intravenous methylene blue. - Previous hypersensitivity reaction to vortioxetine or any components of the formulation. - Clinical worsening symptoms of depression and suicide risk based on investigator judgement. - History of or current diagnosis of Serotonin syndrome. - History of or current Abnormal bleeding. - Previous history or current symptoms of mania/hypomania. - Angle closure glaucoma. - Hyponatremia. - Moderate hepatic impairment. - History of seizures and epilepsy. |
Country | Name | City | State |
---|---|---|---|
Canada | Canadian Rapid Treatment Centre of Excellence | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Brain and Cognition Discovery Foundation | Cognition Kit, Ctrl Group, Ltd, Takeda |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Montgomery and Asberg Depression Rating Scale (MADRS) | Scale that assesses depressive symptoms. The scale has 10 items and is based on the patient's subjective report of his/her clinical condition over the previous 7 days. Additional information is based upon clinical observations made during the course of the clinical interview. Each item assesses a severity rating. All items that are graded on a 0 to 6 scale. The overall MADRS score ranges from 0-60. Higher scores are indicative of more severe depression.Usual cutoff points are: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression. | 1 week | |
Secondary | Hamilton Anxiety Rating Scale (HAM-A) | The HAM-A is a rating scale that measures the severity of anxiety symptoms.The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). | 1 week | |
Secondary | Snaith Hamilton Pleasure Scale (SHAPS ) | The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14 and higher scores are indicative of greater anhedonia. | 1 week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03256162 -
Ketamine as an Adjunctive Therapy for Major Depression
|
Phase 1 | |
Completed |
NCT01944293 -
Ketamine for Suicidality in Bipolar Depression
|
Phase 1/Phase 2 | |
Recruiting |
NCT01441505 -
A Study of Ketamine as an Antidepressant
|
Phase 2 | |
Active, not recruiting |
NCT03487926 -
Microglial Activation in Inflammatory Bowel Disease
|
||
Recruiting |
NCT04939649 -
Ketamine as an Adjunctive Therapy for Major Depression (2)
|
Phase 3 | |
Recruiting |
NCT05028738 -
Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
|
N/A | |
Recruiting |
NCT03646058 -
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
|
Phase 3 | |
Not yet recruiting |
NCT06117397 -
A Text Messaging Intervention to Reduce Perinatal Depression Risk
|
N/A | |
Completed |
NCT03735576 -
Cognitive Behavioural Therapy for the Treatment of Late Life Depression
|
N/A | |
Recruiting |
NCT04999553 -
Left vs. Right Non-Inferiority Trial
|
N/A | |
Completed |
NCT03716869 -
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
|
N/A | |
Recruiting |
NCT02824081 -
Neuroinflammation, Serotonin, Impulsivity and Suicide
|
N/A | |
Terminated |
NCT01099592 -
Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression
|
Phase 4 | |
Completed |
NCT03752853 -
Stress Systems and Psychotherapy in Depression
|
N/A | |
Recruiting |
NCT04480918 -
University of Iowa Interventional Psychiatry Service Patient Registry
|
||
Recruiting |
NCT04130958 -
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
|
N/A | |
Completed |
NCT03190772 -
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
|
N/A | |
Recruiting |
NCT04832750 -
Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep
|
||
Terminated |
NCT02839798 -
NeoSync TMS Treatment for Bipolar I Depression
|
Phase 2 | |
Completed |
NCT00852592 -
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
|
Phase 3 |