Clinical trial

Effect of Benzodiazepine on Corticolimbic Activation, GABA and Glutamate in Subjects at Clinical High Risk of Psychosis

Name
18/LO/0618
Description
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 during tasks and at-rest) in 24 individuals at clinical high-risk for psychosis.
Trial arms
Trial start
2019-07-24
Estimated PCD
2023-03-24
Trial end
2023-03-24
Status
Completed
Treatment
Diazepam 5 Mg Oral Tablet
Single dose given orally (opaque capsule) 60 minutes prior to MRI scan
Arms:
Diazepam/Placebo, Placebo/Diazepam
Other names:
Diazepam
Ascorbic Acid 50 Mg Oral Tablet
Single dose given orally (opaque capsule) 60 minutes prior to MRI scan
Arms:
Diazepam/Placebo, Placebo/Diazepam
Other names:
Placebo
Size
24
Primary endpoint
GABA/Glutamate concentrations (Magnetic Resonance Spectroscopy)
Assessed at 1st and 2nd MRI scan (~2 and ~6 weeks, respectively, after enrolment)
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2024-01-05

1 organization

2 products

1 indication

Product
Diazepam