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

Conditions: Major Depressive Disorder
Treatment Resistant Depression
10027946

Registration Number: NL-OMON54371

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 83

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

- 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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- VTA-related BOLD-signals and habenula-VTA connectivity coding for Temporal<br /><br>Difference Errors in reward/punishment-related learning<br /><br>- [18F]DPA-714 binding potential in the brain </p><br>

Secondary Outcome Measures

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