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| Name | Class |
|---|---|
| University of Bath | OTHER |
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This study is investigating whether acute administration of citalopram is associated with a decrease in stress reactivity in healthy volunteers, compared to placebo administration. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of citalopram or placebo. All participants will have come in for a screening visit. On the day of the research visit (following drug administration) participants will have completed a number of widely used computer-based cognitive tasks measuring emotional processing biases. They will then complete the Oxford Cognition Stress Task, a web-based acute stress induction paradigm, which is designed to induce mild transient increases in stress and arousal. Identifying early changes in stress reactivity following antidepressant treatment will increase the investigator's knowledge of how antidepressants operate, and provide putative targets to identify early response to antidepressants.
In the Oxford Cognition Stress Task (OCST), participants are presented with a series of mental arithmetic, verbal (anagrams) and visuospatial (visual search) challenges on a computer screen. There is a time limit for completing each challenge, which is displayed on the screen as a time bar. To induce a high failure rate, the timing and difficulty of the challenges is automatically varied to ensure participants are correctly complete only 20-40% of the challenges within the time, and some of the verbal challenges (anagrams) are impossible to solve. Participants are given feedback on their performance on the screen which indicates that they are performing badly. Heart rate will be measured continuously during the OCST, and during pre- and post- task periods. Baseline and post-OCST measures of blood pressure and samples of saliva (for cortisol analysis) will be taken. Participants will also complete Visual Analogue Scales pre- and post-OCST to give a subjective measure of stress and mood. Participants will not be told the extent to which becoming stressed (and finding the task difficult) is intended. At the end of the test session, participants will be fully debriefed as to the nature of the OCST.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Citalopram | Experimental | 20mg oral dose of citalopram (tablet encapsulated in opaque capsule) |
|
| Placebo | Placebo Comparator | Lactose placebo (tablet encapsulated in opaque capsule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citalopram | Drug | Single dose administration of citalopram (20mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate (beats per minute) | Difference in heart rate during the Oxford Cognition Stress Task relative to pre-task baseline period between citalopram and placebo groups | Day 1: 4.5-5.5 hours post drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability (Root Mean Square Of Successive Differences: RMSSD) | Difference in RMSSD during the Oxford Cognition Stress Task relative to pre-task baseline period between citalopram and placebo groups | Day 1: 4.5-5.5 hours post drug administration |
| Salivary cortisol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susannah Murphy, DPhil | Contact | 01865 618313 | +44 | susannah.murphy@psych.ox.ac.uk |
| Lucy Wright, MSc | Contact | 01865 613111 | +44 | lucy.wright@psych.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Susannah Murphy, DPhil | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oxford | Recruiting | Oxford | OX3 7JX | United Kingdom |
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| Label | URL |
|---|---|
| PERL Oxford webpage | View source |
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An anonymised dataset will be published as open access data on a secure repository (Open Science Framework https://osf/io/).
Following full anonymisation of study data and publication of findings. Data will be stored indefinitely.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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Following the screening, eligible participants will be randomised to receive either a single 20mg oral dose of citalopram or a matched lactose placebo tablet using an online randomisation tool. Note that the study is not assessing the safety or efficacy of citalopram, rather it is using citalopram to understand the role of serotonin in stress reactivity.
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| Placebo |
| Other |
Lactose placebo tablet |
|
Difference in salivary cortisol following the Oxford Cognition Stress Task relative to pre-task baseline between citalopram and placebo groups; difference in area under the curve for all study timepoints between citalopram and placebo groups |
| Day 1: 4.5-5.5 hours post drug administration |
| Blood pressure | Difference in systolic and diastolic blood pressure following the Oxford Cognition Stress Task relative to pre-task baseline between citalopram and placebo groups | Day 1: 4.5-5.5 hours post drug administration |
| Subjective measures of stress and arousal | Difference in state anxiety, positive and negative affect, and Visual Analogue Scale (VAS) ratings of stress (from 0 to 100, where 0 indicates 'Not at all' and 100 indicates 'Extremely') following the Oxford Cognition Stress Task relative to pre-task baseline between citalopram and placebo groups | Day 1: 4.5-5.5 hours post drug administration |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |