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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
Inclusion Criteria

Moderate or severe diagnosis of MDD based on a structured clinical interview (MINI)
Score of >20 on the MADRS.
Age 18-6

Exclusion Criteria

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
NameTimeMethod
Response or non-response defined as a greater than 50% reduction in MADRS score at week 8 when compared to baseline.
Secondary Outcome Measures
NameTimeMethod
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
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