ew Exploratory Tools, Technologies and Biomarkers to characterize Depressio

Completed

• Conditions: Depression; 10027946

• Registration Number: NL-OMON48699
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2020-07-03
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified