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fMRI signatures of depression and response to antidepressants in early psychosis

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Trial Information

Short Title: FSAREP

Long title: Functional Magnetic Resonance Imaging signatures of depression and response to antidepressants in early psychosis

Contact Details

Study Location:

ESTEEM/CMHT

Centre for Cognitive Neuroimaging (CCNi), University of Glasgow

Principal Investigator

Dr Filippo Queirazza

Email: Filippo.Queirazza@ggc.scot.nhs.uk

Study Overview

FSAREP is an observational study which tests the validity of a novel biomarker as predictor of response to antidepressants in those with Early Psychosis (EP) using functional magnetic resonance imaging (fMRI).

The first five years of psychosis are considered a critical period for intervening to improve long-term outcome. This critical period is usually referred to as EP. Around half of patients presenting with EP will develop depressive symptoms. Similarly, negative symptoms are highly prevalent (i.e. 51%) in EP and often run a chronic course. Crucially, negative and depressive symptom domains significantly overlap and at a phenomenological level are difficult to disentangle. Importantly, whilst antidepressants are efficacious in treating depressive symptoms, the evidence supporting their efficacy in the treatment of negative symptoms remains inconclusive. Hence, a detailed understanding of the neural mechanisms underlying these symptom domains in the context of EP has significant translational potential and will help guide effective treatment selection.

This study is led by NHS Greater Glasgow and Clyde and is financially supported by a SIM fellowship. A total of 65 participants will be recruited from ESTEEM or community mental health teams across NHS Greater Glasgow and Clyde.

The primary objectives of this study are – a) Prediction of response to Selective Serotonin Reuptake Inhibitor (SSRI) treatment at the individual level, and b) Identification of model-based fMRI biomarkers differentiating between negative and depressive symptoms in early psychosis (EP).

Eligibility Criteria

Inclusion:

  1. Male and female age 16- 40 years old
  2. Capacity to give informed consent
  3. Diagnosis of Early Psychosis (first 5 years of receiving psychosis diagnosis)
  4. Scale for the Assessment of Negative Symptoms (SANS) score ≥ 49.
  5. Eligibility to commence SSRI treatment.

Exclusion:

  1. Diagnosis of affective psychotic illness.
  2. Evidence of current substance misuse or dependence.
  3. Significant medical co-morbidity or history of significant brain injury.
  4. Current or intended pregnancy or breastfeeding
  5. Contraindications to MRI scanning
  6. Contraindications to SSRI treatment
  7. Severe adverse reaction/side-effects to SSRI treatment resulting in discontinuation of treatment
Study visits

Participants who meet the eligibility criteria will attend a total of 3 visits comprising of clinical assessments (before and after each participant starts antidepressant treatment) and a single neuroimaging visit.

Visit 1 – 90 minutes

This will take place alongside a routine visit.

  • Written Informed Consent
  • Review Inclusion/Exclusion Criteria
  • MRI safety checklist to screen for any potential contraindications to MRI scanning
  • Scale for the Assessment of Negative Symptoms (SANS)
  • National Adult Reading Test (NART)
  • Hamilton Depression Rating Scale (HDRS)
  • Calgary Depression Scale for Schizophrenia (CDSS).

Scanning appointment at Centre for Cognitive Neuroimaging (CCNi), University of Glasgow will be booked.

Visit 2- 90 minutes:

A return taxi journey will be arranged for participants to attend the scanning visit at CCNi.

  • MRI safety checklist
  • Task based fMRI

Visit 3 – 60 minutes:

After 6 weeks of treatment the research team will arrange to meet the participant in line with a routine visit.

  • SANS
  • HDRS
  • CDSS

 

Patient expenses

Taxi fare for travel to scanning appointment will be paid and at the end of the study participants will receive a £20 Amazon voucher.