Status:
COMPLETED
Investigating the Role of Diazepam on Brain Function and Chemistry in Psychosis Risk
Lead Sponsor:
King's College London
Collaborating Sponsors:
Wellcome Trust
The Royal Society
Conditions:
Prodromal Schizophrenia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
This study will investigate whether a single dose of diazepam (5mg) compared to placebo can modulate brain chemistry (GABA/glutamate levels) and function (blood flow, neural response and connectivity ...
Detailed Description
The pathophysiology of psychosis involves elevated subcortical dopamine function, but the factors driving this are still unclear. Evidence from a neurodevelopmental animal model of psychosis suggests ...
Eligibility Criteria
Inclusion
- Age range 18-40 years
- Capacity to consent to participation in the study
- Inclusion into one of three groups as assessed by the CAARMS: i) genetic vulnerability group, ii) attenuated psychosis group, iii) brief intermittent psychosis symptoms group. This instrument has been modified to additionally allow the scoring of the SIPS v.520. The scoring of the SIPS v.5 is included for comparative purposes and does not constitute inclusion criteria.
- Inclusion based on meeting criteria for "basic symptoms" which are assessed using the Schizophrenia Proneness Instrument (SPI-A)21
Exclusion
- History of neurological disorders
- Current exposure to any drug with potential GABAergic or glutamatergic effects other than antipsychotics, mood stabilisers, antidepressants. This includes opiates, psychostimulants, benzodiazepines, atomoxetine, memantine, ketamine, cough medication containing dextromethorphan
- Current or past exposure to any antipsychotic medication
- Pregnancy/breastfeeding
- Contra-indication to MRI scanning (e.g., metal in body, such as pacemakers or implants, claustrophobia)
- IQ \< 70 as determined with the shortened version of the Wechsler Adult Intelligence Scale III (WAIS-III)22
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06190483
Start Date
July 24 2019
End Date
March 24 2023
Last Update
January 5 2024
Active Locations (1)
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1
Institute of Psychiatry, Psychology and Neuroscience
London, United Kingdom, SE8 5AF