The Effect of SSRIs on Threat of Shock Potentiated Neural Circuitry
- Registration Number
- NCT07074652
- Lead Sponsor
- UCLH/UCL Joint Research Office
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Control - Escitalopram Escitalopram Participants took 10mg escitalopram for 2-3 weeks, once daily. Escitalopram was administered in the form of a tablet, manufactured and donated for research by Lundbeck (tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate; tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000). Exact length of administration was dependent on participants' availability to attend their second scan. Healthy Control - Placebo Placebo Participants took a placebo tablet for 2-3 weeks, once daily. Placebo was administered in the form of a tablet, manufactured and donated for research by Lundbeck and matching the escitalopram tablet given to the other study groups in colour and size. Exact length of administration was dependent on participants' availability to attend their second scan. Anxious Individuals - Escitalopram Escitalopram Participants took 10mg escitalopram for 2-3 weeks, once daily. Escitalopram was administered in the form of a tablet, manufactured and donated for research by Lundbeck (tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate; tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000). Exact length of administration was dependent on participants' availability to attend their second scan. Anxious Individuals - Placebo Placebo Participants took a placebo tablet for 2-3 weeks, once daily. Placebo was administered in the form of a tablet, manufactured and donated for research by Lundbeck and matching the escitalopram tablet given to the other study groups in colour and size. Exact length of administration was dependent on participants' availability to attend their second scan.
- Primary Outcome Measures
Name Time Method 'Aversive amplification circuit' connectivity Baseline and 2-3 weeks after baseline The 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 Outcome Measures
Name Time Method Cognitive task performance: Loss/risk aversion task Baseline and 2-3 weeks after baseline Measures how averse participants are to risk and loss in a mock gambling context
Cognitive task performance: Go/no-go task Baseline and 2-3 weeks after baseline Measures approach/avoidance behaviours under threat of shock or safe conditions
Cognitive task performance: Facial emotional processing task Baseline and 2-3 weeks after baseline Measures brain responses to positive, negative and neutral emotions
Cognitive task performance: Visual affective bias task Baseline and 2-3 weeks after baseline Measures biases in patients' cognition towards or away from rewarding stimuli
Clinical symptom measure: Generalised Anxiety Disorder Scale (GAD-7) Baseline and 2-3 weeks after baseline Measures symptoms of generalised anxiety, scored between 0-21 with higher scores indicating more severe symptoms
Cognitive task performance: Emotional face recognition task Baseline and 2-3 weeks after baseline Measures brain responses during two distinct memory processes - the encoding (learning) and retrieval (remembering) of information
Clinical symptom measures: Beck's Depression Inventory (BDI) Baseline and 2-3 weeks after baseline Measures depressive symptoms, scored between 0-63 with higher scores indicating more severe symptoms
Clinical symptom measures: Catastrophizing questionnaire Baseline and 2-3 weeks after baseline Measures 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 baseline Measures 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 baseline Measures 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 Scale Baseline and 2-3 weeks after baseline Measures 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
Regional activations during neuroimaging task: Facial emotional processing task Baseline and 2-3 weeks after baseline Measures brain responses to positive, negative and neutral emotions
Regional activations during neuroimaging task: Emotional face recognition task Baseline and 2-3 weeks after baseline Measures brain responses during two distinct memory processes - the encoding (learning) and retrieval (remembering) of information
Regional activations during neuroimaging task: Visual affective bias task Baseline and 2-3 weeks after baseline Measures biases in patients' cognition towards or away from rewarding stimuli
Clinical symptom measure: State Trait Anxiety Inventory (STAI) Baseline and 2-3 weeks after baseline Measures 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 baseline Measures depressive symptoms, scored between 0-27 with higher scores indicating more severe symptoms
Trial Locations
- Locations (1)
University College London
🇬🇧London, United Kingdom
University College London🇬🇧London, United Kingdom