Bringing computational psychiatry to clinical practice: Patient stratification for successful administration of intranasal s-ketamine in treatment-resistant depression

Bringing computational psychiatry to clinical practice: Patient stratification for successful administration of intranasal s-ketamine in treatment-resistant depression - ComPass-TRD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56574

Enrollment

Registered

2024-01-08

Start date

2025-11-04

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

hard to treat depression

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: - Clinical diagnosis of primary MDD, preferably confirmed by a structured clinical interview (MINI/SCID-I) - Treatment Resistant Depression, defined as non-response to at least two antidepressants used at adequate dosages for a minimum of 6 weeks - Age >18 years old (no maximum age) - Current use of an antidepressant

Exclusion criteria

Exclusion criteria: Een potentiële proefpersoon die aan een van de volgende criteria voldoet, wordt uitgesloten van deelname aan deze studie: Kan niet spreken, lezen en/of begrijpen van het Nederlands (VMBO-niveau) Voorgeschiedenis van significante neurologische aandoeningen Zwangerschap Mentaal niet bekwaam om toestemming te geven voor informed consent Standaard contra-indicatie voor MRI: o Onveilige metalen of apparaten in het lichaam (cardiale pacemaker, cochleair implantaat, aneurysmaklem) o Eerdere hersenoperatie o Matige tot ernstige claustrofobie

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the change (relative to baseline) in clinician-rated MADRS score (Montgomery 1979) at 4 weeks. On a neural level changes in blood oxygen level dependent (BOLD) signal is the main study parameter, especially within the habenula and circuitry involved in value-based decision-making. On a behavioural level, action-context specific Pavlovian-instrumental-transfer effects are the main study parameters.	—

Measure

Time frame

Primary endpoint is the change (relative to baseline) in clinician-rated MADRS score (Montgomery 1979) at 4 weeks. On a neural level changes in blood oxygen level dependent (BOLD) signal is the main study parameter, especially within the habenula and circuitry involved in value-based decision-making. On a behavioural level, action-context specific Pavlovian-instrumental-transfer effects are the main study parameters.

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Secondary

Measure	Time frame
Changes in resting state functional connectivity as a function of treatment (response) Changes in structural brain characteristics (cortical thickness, subcortical volumes) as a function of treatment (response)	—

Countries

Netherlands

Outcome results