Uncovering Pathophysiologic Mechanisms of Treatment Resistant Depression: A comparison with non-TRD patients

Uncovering Pathophysiologic Mechanisms of Treatment Resistant Depression: A comparison with non-TRD patients - UNCOVER-TRD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54371

Enrollment

Registered

2022-04-25

Start date

2023-06-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder Treatment Resistant Depression

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Males and females between 18-70 years of age - First or recurrent episode of unipolar major depressive disorder - Treatment resistance for at least two antidepressants for the TRD group - Never or only once being treated with antidepressants without effect for the non-TRD group

Exclusion criteria

Exclusion criteria: - ECT within one year prior to the current course - Current use of antidepressants, antipsychotics and mood stabilizers - Use of benzodiazepines within 24 hours before ECT - Use of anti-inflammatory drugs for more than a week in the past month (for patients included for PET-scan only) - Use of immune suppressants (for patients included for PET-scan only) - Presence of current or past relevant somatic disorder - Presence of comorbid bipolar disorder, schizophrenia or substance abuse disorder - MRI- or PET-related exclusion criteria - ECT-related exclusion criteria(for TRD group only) - Low-affinity binder for TSPO (for patients included for PET-scan only)

Design outcomes

Primary

Measure	Time frame
- VTA-related BOLD-signals and habenula-VTA connectivity coding for Temporal Difference Errors in reward/punishment-related learning - [18F]DPA-714 binding potential in the brain	—

Secondary

Measure	Time frame
- Changes in VTA-related BOLD-signals and habenula-VTA connectivity coding for Temporal Difference Errors in reward/punishment-related learning after treatments (SSRI/SNRI in non-TRD group; and ECT in TRD-group; distinction of responders and non-responders) - Serum markers indicative of inflammation and changes thereof after treatment - Clinical symptoms (HDRS-17, IDS-SR, RRS, SHAPS and TEPS) and changes thereof after treatment - Additional MRI-scans (T1 structural, DTI, and resting state) and changes thereof after treatment	—

Measure

Time frame

- Changes in VTA-related BOLD-signals and habenula-VTA connectivity coding for Temporal Difference Errors in reward/punishment-related learning after treatments (SSRI/SNRI in non-TRD group; and ECT in TRD-group; distinction of responders and non-responders) - Serum markers indicative of inflammation and changes thereof after treatment - Clinical symptoms (HDRS-17, IDS-SR, RRS, SHAPS and TEPS) and changes thereof after treatment - Additional MRI-scans (T1 structural, DTI, and resting state) and changes thereof after treatment

—

Countries

Netherlands

Outcome results