EOPARD: Longitudinal Evaluation Of a Predictive Algorithm for Response in Depressio
- Conditions
- Major Depressive Disorder
- Registration Number
- NL-OMON27632
- Lead Sponsor
- EUROSTARS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Moderate or severe diagnosis of MDD based on a structured clinical interview (MINI)
Score of >20 on the MADRS.
Age 18-6
IQ of less than 70 as assessed by the Dutch national adult reading test (Nederlandse Leest-est voor Volwassenen (NLV)).
Alcohol and/or drug dependence according to DSM-5 criteria.
A history of skull fracture or a severe or disabling medical condition.
Contraindications to MRI scanning
Neurological comorbidity or major residual structural differences due to prior neurological pathology
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response or non-response defined as a greater than 50% reduction in MADRS score at week 8 when compared to baseline.
- Secondary Outcome Measures
Name Time Method Response to treatment as a score of 1 or 2 on the Clinical Global Impression Scale (CGI) improvement item (indicating very much improved ”or much improved”) at week 8