7T Amygdala and Citalopram Study

NCT06412315 | Recruiting

• 1 other identifier: 7T_Amygdala_Citalopram
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate how a common antidepressant citalopram (which increases the levels of the chemical messenger serotonin), affects how a key area of the brain involved in depression (the amygdala) responds to emotional information. Healthy participants will undergo medical and psychiatric health screening, after which they will be assigned to receive either a single dose of citalopram (20mg) or placebo, and undergo brain scanning (7T fMRI) whilst viewing emotional faces. Since the scan uses high field strength, the investigators will be able to see effects of citalopram on different subfields within the amygdala which will help to understand how citalopram might be working.

Conditions

Emotional Processing; Cognition; Mood Disorders; Depressive Disorder; Depression

Keywords

Antidepressants; Experimental medicine; Psychopharmacology; Emotional Processing; fMRI; High field strength fMRI; 7 Tesla MRI

Outcome Measures

Primary Outcomes (2)

• Neural measures: fMRI BOLD univariate analysis

  Blood-oxygen-level-dependent (BOLD) fMRI (region of interest (ROI) analysis amygdala) during the performance of an emotional faces task. Differential amygdala response to fearful and happy faces. Univariate analysis

  3 hours after dosing for approximately 1 hour

• Neural measures: fMRI BOLD multivariate analysis

  Blood-oxygen-level-dependent (BOLD) fMRI (region of interest (ROI) analysis amygdala) during the performance of an emotional faces task. Amygdala response to fearful and happy faces. Multivariate pattern analysis.

  3 hours after dosing for approximately 1 hour

Secondary Outcomes (2)

• Behavioural measures: Accuracy during gender discrimination task

  3 hours after dosing for approximately 1hour

• Behavioural measures: Reaction times during gender discrimination task

  3 hours after dosing for approximately 1hour

Study Arms (2)

Citalopram

EXPERIMENTAL

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Citalopram DRUG

Participants will receive a single dose (20mg) citalopram. Tablets encapsulated to aid blinding. To take per oral once.

Citalopram

Placebo DRUG

Participants will receive a single dose of placebo (sucrose). Tablets encapsulated to aid blinding. To take per oral once

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the research
• Sufficiently fluent English to understand and complete the task

You may not qualify if:

• Participants with ferromagnetic objects in their bodies (e.g. metal implants, vessel clips, shrapnel injuries) or with implanted devices which may be damaged by the magnet (e.g. heart pacemakers)
• Any other MRI contraindication following MRI safety screening
• History or current significant psychiatric illness (like major depressive disorder)
• Current or past diagnosis of any significant personality disorder (e.g. borderline personality disorder) according to self-report
• Diagnosis of attention deficit hyperactive disorder or autistic spectrum disorder that impairs daily functioning, requires pharmacotherapy or in the opinion of the study medic would affect the scientific integrity of the study
• Currently or within last 3 months taking psychoactive medications (requires further discussion with researcher)
• Current or within the last 3 months use of medication that might interact with the effects of citalopram or affect the scientific integrity of the study
• Known contraindication to citalopram including: past allergic reaction to citalopram or any other medicines, diagnosis of a cardiovascular condition, glaucoma, type 1 or type 2 diabetes, diagnosis of epilepsy, previous diagnosis of angle-closure glaucoma, or current use of any other medication whose use interacts with citalopram (according to British National Formulary (BNF) guidance) e.g. associated with prolonged QT-interval
• Any other current or past medical conditions which in the opinion of the study medic may interfere with the safety of the participant or the scientific integrity of the study including epilepsy/seizures, brain injury, hepatic or renal disease, diabetes, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological conditions
• Clinically significant abnormal values for urine drug screen, pulse, and blood pressure measurement (in accordance with Best Practice Guidance 13: 'Non-invasive measurement of blood pressure'). A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
• Current alcohol or substance misuse disorder
• Body Mass Index under 18 and over 30
• Pregnant or planning a pregnancy, or breast feeding
• Previously taken part in a study that used similar computer tasks (MRI faces task, emotional test battery) as those in the present study
• Participation in a study that involves the use of a psychoactive medication or brain stimulation within the last three months

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford, Department of Psychiatry

Oxford, Oxfordshire, OX37JX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Depressive Disorder; Depression

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Marieke AG Martens, DPhil

CONTACT

+441865 618338; marieke.martens@psych.ox.ac.uk

Catherine J Harmer, DPhil

CONTACT

+441865 618326; catherine.harmer@psych.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All members of the study team will be blinded to the condition a participant is allocated to with the exception of the team member responsible for treatment allocation (who will not interact with the participant).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cognitive Neuroscience

Model Details: Participants will be assigned to receive citalopram or placebo. Citalopram is not being administered for treatment purposes, the purpose is to understand the mechanisms underpinning its effects (no clinical outcome measure). A double-blind randomised placebo-controlled design (25 participants in each group) will be used, with 1 single dose of citalopram (20mg) or placebo.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: May 14, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

GB (1)