Investigating the Role of Diazepam on Brain Function and Chemistry in Psychosis Risk

NCT06190483 | Completed

• 1 other identifier: 18/LO/0618
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 during tasks and at-rest) in 24 individuals at clinical high-risk for psychosis.

Conditions

Prodromal Schizophrenia

Outcome Measures

Primary Outcomes (1)

• GABA/Glutamate concentrations (Magnetic Resonance Spectroscopy)

  To evaluate the acute effect of a benzodiazepine drug (diazepam) on GABA and glutamate concentrations in people at clinical high risk of psychosis (CHR).

  Assessed at 1st and 2nd MRI scan (~2 and ~6 weeks, respectively, after enrolment)

Secondary Outcomes (4)

• Cerebral blood flow (Arterial Spin Labelling)

  Assessed at 1st and 2nd MRI scan (~2 and ~6 weeks, respectively, after enrolment)

• Functional connectivity (Resting State Functional Magnetic Resonance Imaging)

  Assessed at 1st and 2nd MRI scan (~2 and ~6 weeks, respectively, after enrolment)

• Neural response to emotional stimuli (Task Based Functional Magnetic Resonance Imaging)

  Assessed at 1st and 2nd MRI scan (~2 and ~6 weeks, respectively, after enrolment)

• Neural response during working memory (Task Based Functional Magnetic Resonance Imaging)

  Assessed at 1st and 2nd MRI scan (~2 and ~6 weeks, respectively, after enrolment)

Study Arms (2)

Diazepam/Placebo

EXPERIMENTAL

Participant\'s receive diazepam on 1st MRI scan, and placebo (ascorbic acid) on 2nd MRI scan

Drug: Diazepam 5 Mg Oral Tablet; Drug: Ascorbic Acid 50 Mg Oral Tablet

Placebo/Diazepam

EXPERIMENTAL

Participant\'s receive placebo (ascorbic acid) on 1st MRI scan, and diazepam on 2nd MRI scan

Drug: Diazepam 5 Mg Oral Tablet; Drug: Ascorbic Acid 50 Mg Oral Tablet

Interventions

Diazepam 5 Mg Oral Tablet DRUG

Single dose given orally (opaque capsule) 60 minutes prior to MRI scan

Also known as: Diazepam

Diazepam/Placebo; Placebo/Diazepam

Ascorbic Acid 50 Mg Oral Tablet DRUG

Single dose given orally (opaque capsule) 60 minutes prior to MRI scan

Also known as: Placebo

Diazepam/Placebo; Placebo/Diazepam

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range 18-40 years
• Capacity to consent to participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Wellcome Trust: collaborator
• The Royal Society: collaborator

Study Sites (1)

Institute of Psychiatry, Psychology and Neuroscience

London, SE8 5AF, United Kingdom

Location

MeSH Terms

Conditions

Schizotypal Personality Disorder

Interventions

Diazepam; Tablets; Ascorbic Acid

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: July 24, 2019
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)