Depression
Conditions
Interventions
None listed
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: 1. Written informed consent must be obtained before any assessment is performed. 2. Males and females, age 18 to 65 years (inclusive). 3. Subjects must be diagnosed by the attending general practitioner, psychiatrist or clinical psychologist with, and meet the diagnostic criteria for at least one of the following disorders as confirmed with the Mini International Neuropsychiatric Interview (MINI): 4. Current major depressive disorder (MDD) without psychotic features according to DSM-5 (296.22, 296.23, 296.32, 296.33). 5. Current persistent depressive disorder (PDD) or dysthymia according to the DSM-5 (300.4). 6. Total HAMD-17 total score of >16 at Screening. 7. Use of mono-aminergic antidepressant drug (SSRI, SNRI, mirtazapine, TCA, MAO-I) at a stable dose for at least 4 weeks (6 weeks for fluoxetine). 8. Must read and speak both Dutch and English as a first or second language. 9. Subjects must own and use a personal computer (desktop or laptop) using the Windows operating system 10. Able to comply with the study procedures, prohibitions and restrictions (drug and alcohol use) as specified in the protocol. 11. Android-based smartphone , Healty volunteers : 1. Written informed consent must be obtained before any assessment is performed. 2. Male or female subjects, 18 to 65 years (inclusive) 3. Body mass index (BMI) between 18 and 30 kg/m2. 4. Must read and speak both Dutch and English as a first or second language. 5.Subjects must own and use a personal computer (desktop or laptop) using the Windows operating system. 6. Able to comply with the study procedures, prohibitions and restrictions (drug and alcohol use) as specified in the protocol. 7. Android-based smartphone
Exclusion criteria
Exclusion criteria: Patients: 1. Current primary DSM-5 diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa or cluster C personality disorder (e.g. avoidant, dependent, obsessive-compulsive personality disorders). Subjects for whom the diagnosed mood disorder (MDD, PDD or dysthymia) is considered the primary diagnosis are not excluded. 2. Current or previously diagnosed psychotic disorder, mood disorder with psychotic features, bipolar disorder, mental retardation, cluster B personality disorder (e.g., borderline, antisocial, narcissistic personality disorders). 3. Current or recent history of clinically significant suicidal thoughts or ideation within the past 12 months or any suicidal behavior within the past 6 months as demonstrated with the C-SSRS should be carefully screened and only included at the discretion of the investigator. 4. Positive urine test for drugs of abuse at Screening or on study days or a current diagnosis of substance use disorder (including alcohol but excluding nicotine), or previous substance use disorder (including alcohol but excluding nicotine) within the past 12 months according to DSM-5. 5. Evidence of renal, hepatic, cardiovascular or metabolic dysfunction or any active or chronic disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the investigator to have no clinical relevance. 6. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during Screening may be repeated before randomization to confirm eligibility or to assist in evaluating clinical relevance. 7. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or to assist in evaluating clinical relevance. 8. Positive urine *-human chorionic gonadotropin (*-hCG) pregnancy test at Screening in women of childbearing potential. 9. Current enrollment in an interventional study., Healthy volunteers: 1. Current or previous clinically relevant history or family history of psychiatric disorders, neurological disorders or neurosurgery. 2. Positive urine test for drugs of abuse at Screening or on study days or a current diagnosis of substance use disorder (including alcohol but excluding nicotine) or previous substance use disorder (including alcohol but excluding nicotine) within the past 12 months according to DSM-5. 3. Evidence of renal, hepatic, cardiovascular or metabolic dysfunction or any active or chronic disease or condition that could interfere with the conduct of the study, or th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini International Neuropsychiatric Interview (MINI) Structured Interview for the Hamilton Rating Scale for Depression (SIGHD-IDS) Montgomery-Åsberg Depression Rating Scale Structured Interview Guide (MADRS-SIGMA) Quick Inventory of Depressive Symptomatology (QIDS-SR) self-reportversion Columbia Suicide Severity Rating Scale (C-SSRS). Depression Stress Scales (DASS) WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) ElMindA Cognitive Tests (Brain Network Activation) Cambridge Cognition, CognitionKit (cognition and mood assessments) Sonde Health (voice sampling procedure, vocal analytics) NeuroCart (Neuropsychological Test Battery) BeHapp (social interactions) Neurotrack (eye movement) Emotional Bias Task (EBT) F1l | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory (fluid) Biomarkers : Metabolic, inflammatory, and disease state markers including but not limited to the following: BDNF, D-serine, IL-6, CRP, TNF-alpha, IFN-gamma, IL- 1beta, IL-1Ra, IL-4, IL-13 and Tryptophan/kynurenine pathway metabolites. Exploratory genetic markers including but not limited to polymorphisms associated with disease may also be examined. | — |
Countries
Netherlands
Outcome results
None listed