Citalopram and Stress Reactivity

Sponsor
University of Oxford (Other)
Overall Status
Unknown status
CT.gov ID
NCT04161209
Collaborator
University of Bath (Other)
40
Enrollment
1
Location
2
Arms
10.7
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Effect of Acute Citalopram on Response to Acute Stress Induction
Actual Study Start Date :
Oct 11, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Drug: Citalopram

20mg oral dose of citalopram (tablet encapsulated in opaque capsule)

Drug: Citalopram
Single dose administration of citalopram (20mg)

Placebo Comparator: Placebo

Lactose placebo (tablet encapsulated in opaque capsule)

Other: Placebo
Lactose placebo tablet

Outcome Measures

Primary Outcome Measures

  1. Heart rate (beats per minute) [Day 1: 4.5-5.5 hours post drug administration]

    Difference in heart rate during the Oxford Cognition Stress Task relative to pre-task baseline period between citalopram and placebo groups

Secondary Outcome Measures

  1. Heart rate variability (Root Mean Square Of Successive Differences: RMSSD) [Day 1: 4.5-5.5 hours post drug administration]

    Difference in RMSSD during the Oxford Cognition Stress Task relative to pre-task baseline period between citalopram and placebo groups

  2. Salivary cortisol [Day 1: 4.5-5.5 hours post drug administration]

    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

  3. Blood pressure [Day 1: 4.5-5.5 hours post drug administration]

    Difference in systolic and diastolic blood pressure following the Oxford Cognition Stress Task relative to pre-task baseline between citalopram and placebo groups

  4. Subjective measures of stress and arousal [Day 1: 4.5-5.5 hours post drug administration]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of OxfordOxfordUnited KingdomOX3 7JX

Sponsors and Collaborators

  • University of Oxford
  • University of Bath

Investigators

  • Principal Investigator: Susannah Murphy, DPhil, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
drsusannahmurphy, Senior Research Fellow, University of Oxford
ClinicalTrials.gov Identifier:
NCT04161209
Other Study ID Numbers:
  • OCST_Citalopram
First Posted:
Nov 13, 2019
Last Update Posted:
Nov 15, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by drsusannahmurphy, Senior Research Fellow, University of Oxford
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2019