Depression Clinical Trial
Official title:
The Effect of Acute Citalopram on Response to Acute Stress Induction
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Male or Female - Aged 18 -45 years - Fluent in written and spoken English at a sufficient level to understand and complete the tasks - Body Mass Index (BMI) 18-30 - Participant is willing and able to give informed consent for participation in the study - Not currently taking any regular medications (expect the contraceptive pill) Exclusion Criteria: - Any past or current Axis 1 DSM-V psychiatric disorder - Current use of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant) or medication which may affect the stress response (e.g. corticosteroids, beta-blockers) - Current or past history of drug or alcohol dependency - History of current significant neurological condition (e.g. epilepsy) or heart disease/hypertension - Known hypersensitivity to the study drug - Currently pregnant or breast feeding - Previous participation in a study that uses the same or similar computer tasks as those used in the present study - Previous participation in a study that involves the use of a medication within the last three months - Significant medical condition - Smokers consuming > 5 cigarettes per day - Individuals consuming > 6 caffeinated drinks per day - Lactose Intolerance (due to the study involving administration of a lactose placebo tablet) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | University of Bath |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Salivary cortisol | 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 | |
Secondary | 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 | |
Secondary | 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 |
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