DepressionNCT04161209
Citalopram and Stress Reactivity
A study testing Citalopram in people with Depression and Depressive Disorder, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Disorder, Mental Disorder
- What is being tested?
- Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Oct 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, OX3 7JX
Susannah Murphy, DPhil
About this study
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.
Read the 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.
- Conditions
- Depression, Depressive Disorder, Mental Disorder, Antidepressive Agents, Cognition, Stress
- Being tested
- Citalopram, Placebo
- Keywords
- Citalopram, Stress induction paradigm, Healthy volunteers
- Medical subject headings
- Depression, Depressive Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Single dose administration of citalopram (20mg)
PlaceboOther
Lactose placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Drug: Citalopram | Experimental | 20mg oral dose of citalopram (tablet encapsulated in opaque capsule) Receives: Drug: Citalopram |
| Placebo | Placebo comparator | Lactose placebo (tablet encapsulated in opaque capsule) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1: 4.5-5.5 hours post drug administration
Secondary outcomes (4)
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
Measured: Day 1: 4.5-5.5 hours post drug administration
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
Measured: 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
Measured: 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
Measured: Day 1: 4.5-5.5 hours post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start11 Oct 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath
- Responsible party
- Principal investigator, drsusannahmurphy, University of Oxford
- Investigators
- Susannah Murphy, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161209
- Sponsor's protocol ID
- OCST_Citalopram
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised dataset will be published as open access data on a secure repository (Open Science Framework https://osf/io/).
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Citalopram on Response to Acute Stress Induction
- ClinicalTrials.gov ID
- NCT04161209
- Acronym / sponsor ID
- OCST_Citalopram
- Conditions
- Depression, Depressive Disorder, Mental Disorder, Antidepressive Agents, Cognition, Stress
- Keywords
- Citalopram, Stress induction paradigm, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Bath
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Drug: Citalopram | Experimental | Drug: Citalopram20mg oral dose of citalopram (tablet encapsulated in opaque capsule) |
| Placebo | Placebo comparator | Other: PlaceboLactose placebo (tablet encapsulated in opaque capsule) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramSingle dose administration of citalopram (20mg) | Drug | Drug: Citalopram |
| PlaceboLactose placebo tablet | Other | Placebo |
Primary outcome
Heart rate (beats per minute)
Time frame: 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
4 secondary outcomes
Heart rate variability (Root Mean Square Of Successive Differences: RMSSD)
Time frame: Day 1: 4.5-5.5 hours post drug administration
Salivary cortisol
Time frame: Day 1: 4.5-5.5 hours post drug administration
Blood pressure
Time frame: Day 1: 4.5-5.5 hours post drug administration
Subjective measures of stress and arousal
Time frame: Day 1: 4.5-5.5 hours post drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- PERL Oxford webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. An anonymised dataset will be published as open access data on a secure repository (Open Science Framework https://osf/io/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susannah Murphy, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citalopram in people with Depression and Depressive Disorder, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susannah Murphy, DPhil (01865 618313 ext. +44, susannah.murphy@psych.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (beats per minute) (time frame: Day 1: 4.5-5.5 hours post drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.