ongitudinal evaluation of an MRI-based predictive algorithm for early assessment of treatment response in depression (LEOPARD study)

Recruiting

Conditions: depression
Major Depressive Disorder
10027946

Registration Number: NL-OMON55321

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Moderate or severe diagnosis of MDD - based on a structured clinical
interview (MINI) - score of >20 on the MADRS score, and in need of
pharmacological treatment with AD according to their physician and existing
guide-lines.
- Free of psychotropic medications for at least 5 half-lives (e.g. 1 week for
most antidepressants, 5 weeks for fluoxetine) at baseline.
- Fluency in Dutch, sufficient to complete the interviews and self-report
questionnaires.

Exclusion Criteria

- IQ < 70 based on national adult reading test (Nederlandse Leestest voor
Volwassenen)
- Contraindications to MRI scanning
- Neurological comorbidities

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Response or non-response. In accordance with the CAN-BIND study7, response is<br /><br>defined as a greater than 50% reduction in MADRS score8 at week 8 when compared<br /><br>to baseline. Success of the DEPREDICT algorithm to predict treatment response<br /><br>will be judged based on the calculated sensitivity/specificity of the algorithm<br /><br>(which is based on both baseline-, and/or the 2 week MRI scan, as well as<br /><br>clinical variables and information on sleep and activity) to predict clinical<br /><br>outcome (MADRS-non-response). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Response to treatment as a score of 1 or 2 on the Clinical Global<br /><br>Impression Scale (CGI) improvement item (indicating very much improved or<br /><br>much improved) at week 8. Partial response is defined as a score of 3 on the<br /><br>improvement item. Worsening of depression is defined as a CGI improvement item<br /><br>score of 5, 6, or 7 at week 8.<br /><br>- Inventory of Depressive Symptomatology - Self Rated (IDS-SR)<br /><br>- Morisky questionnaire for medication adherence<br /><br>- Self-reported anhedonia using the Dimensional Anhedonia Rating Scale (DARS)</p><br>