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LEOPARD: Longitudinal Evaluation Of a Predictive Algorithm for Response in Depression

Longitudinal evaluation of an MRI-based predictive algorithm for early assessment of treatment response in depression

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27632
Enrollment
80
Registered
2020-09-08
Start date
2020-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Major Depressive Disorder

Interventions

Questionnaires and non-invasive MRI scanning.

Sponsors

EUROSTARS
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Contacts

Public ContactMaarten Poirot

Amsterdam UMC

m.g.poirot@amsterdamumc.nl0622605934

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)