Status:
COMPLETED
The Antidepressant Advisor (Study 3): fMRI Study to Predict Treatment Response in Patients With Depression
Lead Sponsor:
King's College London
Collaborating Sponsors:
NHS Lambeth Clinical Commissioning Group
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Brief Summary
This prospective observational study (ADeSS-Study3) investigates candidate biomarkers prospectively predicting response to antidepressant medications and prognosis in major depressive disorder (MDD). ...
Detailed Description
This prospective observational study focuses on identifying the neural signatures prospectively predicting poor prognosis in MDD patients after receiving four months of treatment in UK primary care. ...
Eligibility Criteria
Inclusion
- age 18 years +
- at least moderately severe major depressive syndrome on PHQ-9 (score 15 +)
- no plans to change GP practice
- able to complete self-report scales orally or in writing
- no previous prescription of mirtazapine or vortioxetine
- early treatment resistance as defined by 1) current or recent prescription (in the last 2 months) of any of the following antidepressants: citalopram, fluoxetine, sertraline, escitalopram, paroxetine, venlafaxine, or duloxetine AND 2) previous prescription of at least one other antidepressant out of the same list.
Exclusion
- inability to consent to study
- unstable medical condition
- currently receiving specialist psychiatric treatment
- high suicide risk (MINI suicidality screen)
- past diagnosis of schizophrenia or schizo-affective disorder
- current psychotic symptoms (3 clinical screening questions)
- bipolar disorder
- currently at risk of being violent
- drug (modified PHQ) or alcohol abuse (PHQ) over last 6 months
- suspected central neurological condition
- pregnancy or insufficient contraception in women of childbearing age
- breastfeeding or within 6 months of giving birth in women of childbearing age
- both escitalopram and sertraline have already been prescribed
- MRI contraindications
Key Trial Info
Start Date :
August 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04342299
Start Date
August 1 2018
End Date
November 18 2021
Last Update
January 5 2023
Active Locations (1)
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1
King's College London, IoPPN
London, United Kingdom, SE5 8AF