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The Effect of SSRIs on Threat of Shock Potentiated Neural Circuitry

The Effect of SSRIs on Threat of Shock Potentiated Neural Circuitry

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07074652
Enrollment
145
Registered
2025-07-20
Start date
2017-12-01
Completion date
2022-06-30
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

anxiety, selective serotonin reuptake inhibitor, emotion, functional magnetic resonance imaging

Brief summary

This study aims to increase the knowledge about psychological processes which may contribute to mental health problems such as depression and anxiety. This study aims to investigate if administering Escitalopram, an antidepressant which increases serotonin levels in parts of the brain, affects how the brain processes emotional information. It is hoped that measuring these changes will increase the understanding of processes involved in mental health problems.

Interventions

DRUGEscitalopram

Participants received 2-3 weeks of escitalopram.

DRUGPlacebo

Participants received 2-3 weeks of placebo, matched in colour and size to the escitalopram.

Sponsors

University College, London
CollaboratorOTHER
UCLH/UCL Joint Research Office
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Controls: * Fluency in English * Registration with a UK General Practitioner * Capacity for consent * No personal history of long-term medical conditions or psychiatric illness (including substance dependence, assessed with the Mini International Neuropsychiatric Interview) Anxious Individuals: * Fluency in English * Registration with a UK General Practitioner * Capacity for consent * Meeting criteria for generalised anxiety disorder, panic disorder and/or agoraphobia (also assessed with the Mini International Neuropsychiatric Interview); permitted comorbid conditions were: major depressive disorder, obsessive-compulsive disorder and/or post-traumatic stress disorder

Exclusion criteria

Healthy Controls and Anxious Individuals: * Having consumed alcohol within 12 hours prior to the study * having used illicit drugs within 3 months prior to the study * Having had any contraindications to MRI scanning * Being pregnant or breastfeeding * Having had impaired or uncorrected vision or hearing

Design outcomes

Primary

MeasureTime frameDescription
'Aversive amplification circuit' connectivityBaseline and 2-3 weeks after baselineThe engagement of the neural circuit of the amygdala, cingulate cortex and prefrontal cortex will be measured via an fMRI analysis technique called a psychophysiological interactions (PPI) analysis. PPI analysis concerns behaviour-specific increases in the relationship across regional brain activity - this means that it can allow one to assess whether two regions (a priori selected ROIs) show increased connectivity during a specific context or behaviour, suggesting a behaviour-specific increase in transfer of information. The output of this analysis will take form of a continuous beta weight - an index of connectivity across two brain regions (amygdala and medial prefrontal cortex), which represents the primary outcome of the study.

Secondary

MeasureTime frameDescription
Cognitive task performance: Go/no-go taskBaseline and 2-3 weeks after baselineMeasures approach/avoidance behaviours under threat of shock or safe conditions
Cognitive task performance: Facial emotional processing taskBaseline and 2-3 weeks after baselineMeasures brain responses to positive, negative and neutral emotions
Cognitive task performance: Emotional face recognition taskBaseline and 2-3 weeks after baselineMeasures brain responses during two distinct memory processes - the encoding (learning) and retrieval (remembering) of information
Cognitive task performance: Visual affective bias taskBaseline and 2-3 weeks after baselineMeasures biases in patients' cognition towards or away from rewarding stimuli
Regional activations during neuroimaging task: Facial emotional processing taskBaseline and 2-3 weeks after baselineMeasures brain responses to positive, negative and neutral emotions
Regional activations during neuroimaging task: Emotional face recognition taskBaseline and 2-3 weeks after baselineMeasures brain responses during two distinct memory processes - the encoding (learning) and retrieval (remembering) of information
Regional activations during neuroimaging task: Visual affective bias taskBaseline and 2-3 weeks after baselineMeasures biases in patients' cognition towards or away from rewarding stimuli
Cognitive task performance: Loss/risk aversion taskBaseline and 2-3 weeks after baselineMeasures how averse participants are to risk and loss in a mock gambling context
Clinical symptom measure: State Trait Anxiety Inventory (STAI)Baseline and 2-3 weeks after baselineMeasures state and trait anxiety symptoms, scored between 20-80 with higher scores indicating more severe symptoms
Clinical symptom measures: Patient Health Questionnaire (PHQ-9)Baseline and 2-3 weeks after baselineMeasures depressive symptoms, scored between 0-27 with higher scores indicating more severe symptoms
Clinical symptom measures: Beck's Depression Inventory (BDI)Baseline and 2-3 weeks after baselineMeasures depressive symptoms, scored between 0-63 with higher scores indicating more severe symptoms
Clinical symptom measures: Catastrophizing questionnaireBaseline and 2-3 weeks after baselineMeasures catastrophising, scored between 24-120 with higher scores indicating more severe symptoms
Clinical symptom measures: Daily Stress Inventory (DSI)Baseline and 2-3 weeks after baselineMeasures frequency and impact of daily stresses. Frequency scored between 0-58 and impact scored between 0-6, with higher scores indicating more severe stress
Clinical symptom measures: Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS)Baseline and 2-3 weeks after baselineMeasures drive, fun-seeking, reward responsiveness and behavioural inhibition. Behavioural inhibition scored between 7-28, drive between 4-16, fun seeking between 4-16, and reward between 5-20, with higher scores indicating higher levels of those behaviours
Clinical symptom measures: Eysenck Impulsiveness ScaleBaseline and 2-3 weeks after baselineMeasures impulsiveness, venturesomeness and empathy. Impulsivity scored between 0-19, venturesomeness between 0-16, empathy between 0-18, with higher scores indicating higher levels of those traits
Clinical symptom measure: Generalised Anxiety Disorder Scale (GAD-7)Baseline and 2-3 weeks after baselineMeasures symptoms of generalised anxiety, scored between 0-21 with higher scores indicating more severe symptoms

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026