Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06412315
Other study ID # 7T_Amygdala_Citalopram
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date October 31, 2025

Study information

Verified date May 2024
Source University of Oxford
Contact Marieke AG Martens, DPhil
Phone +441865 618338
Email marieke.martens@psych.ox.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Antidepressants typically decrease amygdala response to negative stimuli while enhancing response to positive stimuli, but it is unclear at a mechanistic level how increasing serotonin would have this opposing effect. One hypothesis is that although positive and negative cues activate the same area at a global level, more detailed characterisation may reveal key differences in processing in terms of localisation or response function. Until now, due to methodological restriction, the amygdala has been mostly studied as a single structure. It is however known that it consists of a number of subfields, which are likely to play distinct roles in emotional processing. In this study the investigators will make use of 7T fMRI scanning to study the effects of a single dose (20 mg) of citalopram (selective serotonin reuptake inhibitor, SSRI) on these subfields during emotional face processing, allowing greater precision to identify underlying neural mechanisms underpinning psychological effects.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Participant is willing and able to give informed consent for participation in the research - Sufficiently fluent English to understand and complete the task Exclusion Criteria: - 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 - Use of recreational drugs (e.g. cannabis, cocaine, amphetamines) within last three months - Smoking > 5 cigarettes per day, or vape a comparable amount (> 0.5ml / a quarter of a 2ml vape); - Typically drinks > 6 caffeinated drinks per day (e.g. tea, coffee, coca cola, Red Bull) - Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator

Study Design


Intervention

Drug:
Citalopram
Participants will receive a single dose (20mg) citalopram. Tablets encapsulated to aid blinding. To take per oral once.
Placebo
Participants will receive a single dose of placebo (sucrose). Tablets encapsulated to aid blinding. To take per oral once

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Behavioural measures: Accuracy during gender discrimination task Accuracy (% correct) of gender identification will be measured to ensure participant engagement throughout the task. 3 hours after dosing for approximately 1hour
Secondary Behavioural measures: Reaction times during gender discrimination task Reaction times (ms) of gender identification will be measured to ensure participant engagement throughout the task. 3 hours after dosing for approximately 1hour
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A