Neuro MRI Biomarkers for Treatment Navigation in Depression

Summary

Background of the study:

Major depressive disorder is a severe neuropsychiatric condition that affects approximately 15% to 18% of people worldwide during their lifetime (Malhi \& Mann, 2018). Selection of the optimal treatment is difficult.

A certain correlation (functional / structural, vascular or a mix of both) is expected between clinical data (obtained from psychometric tests such as the HDRS and psychiatric evaluations) and MRI parameters (functional activity, structural connectivity, anatomical variations, perfusion / diffusion etc.).

Objective of the study:

Identification of MRI-based biomarkers to predict clinical outcome of major depressive disorder in comparison with healthy controls. Outcome is defined by level of depressive and cognitive symptomatology and related comorbidity.

Study design:

An independent treating physician will inform a potentially eligible patient and ask whether he/she is interested in voluntary participation in the study. If he/she is interested, the independent treating physician will refer the patient to one of the clinicians from the GGz who is also involved in the Neurotrend study for further steps such as providing the information letter / informed consent and scheduling an intake interview at least one week after receiving all necessary information. Healthy controls will be recruited through public advertisement and via the website www.neurotrend.nl. Pilot subjects will be recruited from the Eindhoven University community and via the website www.neurotrend.nl. Both groups, healthy controls and pilot subjects, will have at least one week to consider and decide on participation. One week later an intake session will take place in which the inclusion and exclusion criteria will be checked. During this session, patients can also ask questions about the study and the informed consent will be signed if the participant is willing to participate voluntarily in the study. Subsequently at the end of the intake session, a starting (baseline) date will be planned for this participant . The actual participation starts at baseline. In total, 120 depressed patients and 60 healthy controls will participate in the study.

Each participant visits Kempenhaeghe twice, whereby each session, is dedicated to complete questionnaires and cognitive tests, such as memory tasks and eye tracking. In the last hour, the participant will be scanned (MRI). Two weeks before each visit, the participant has to fill in some questionnaires that have been sent to the participant.

Study population:

120 patients with major depressive disorder and 60 healthy controls\*.

\* Inclusion of up to 30 healthy "pilot" participants for technical evaluation. See above.

Primary study parameters/outcome of the study:

* Hamilton Depression Rating Scale (HDRS) scores
* Treatment / medication usage
* MRI metrics (varies per MRI modality, an example is volume per region for a T1-weighted scan and fractional anisotropy for diffusion-weighted scans).

Secondary study parameters/outcome of the study (if applicable):

* Scores of psychometric assessments (e.g. STAI-DY1 - anxiety score)
* Scores of cognitive assessments (e.g. average response time for the eye-tracking task)

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

The participant burden is low and is divided into an intake session and two research sessions. The MRI scan is non-invasive, and subjects can indicate that they want to stop the scan at any time during the scan by squeezing a type of balloon that will lie next to the subject in the case that they feel uncomfortable or for any other reason. Subjects with MRI contraindications (e.g.

claustrophobia, pregnancy or implants not suitable for MRI) are already excluded in advance and will therefore not participate in the study at all. Mostly, the subjects will lie still during the scan, except for one affective task in which they will be asked to match different emotional faces for about 5 minutes.The cognitive tests will only consist of memory, reaction speed, attention, and processing speed tasks which in total, do not last more than 30 minutes. The risks of the MRI scanner (CE-marked) are minimal.

Conditions

• Depressive Disorder, Major

Interventions

DEVICE

MRI research

3T MRI protocol of \~1 hour

Sponsors & Collaborators

• Clinical Trial Center Maastricht B.V.

  collaborator OTHER

• Eindhoven University of Technology

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2023-04-28

Completion

2023-04-28

Countries

• Netherlands

Study Locations