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Citalopram and Stress Reactivity

Primary Purpose

Depression, Depressive Disorder, Mental Disorder

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Citalopram

Placebo

About this trial

This is an interventional basic science trial for Depression focused on measuring Citalopram, Stress induction paradigm, Healthy volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of OxfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug: Citalopram

Placebo

Arm Description

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

Lactose placebo (tablet encapsulated in opaque capsule)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT04161209

First Posted

November 8, 2019

Last Updated

November 13, 2019

Sponsor

University of Oxford

Collaborators

University of Bath

1. Study Identification

Unique Protocol Identification Number

NCT04161209

Brief Title

Citalopram and Stress Reactivity

Official Title

The Effect of Acute Citalopram on Response to Acute Stress Induction

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 11, 2019 (Actual)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oxford

Collaborators

University of Bath

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Depressive Disorder, Mental Disorder, Antidepressive Agents, Cognition, Stress

Keywords

Citalopram, Stress induction paradigm, Healthy volunteers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug: Citalopram

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Lactose placebo (tablet encapsulated in opaque capsule)

Intervention Type

Drug

Intervention Name(s)

Citalopram

Intervention Description

Single dose administration of citalopram (20mg)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Lactose placebo tablet

Primary Outcome Measure Information:

Title

Heart rate (beats per minute)

Description

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

Time Frame

Day 1: 4.5-5.5 hours post drug administration

Secondary Outcome Measure Information:

Title

Heart rate variability (Root Mean Square Of Successive Differences: RMSSD)

Description

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

Time Frame

Day 1: 4.5-5.5 hours post drug administration

Title

Salivary cortisol

Description

Time Frame

Day 1: 4.5-5.5 hours post drug administration

Title

Blood pressure

Description

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

Time Frame

Day 1: 4.5-5.5 hours post drug administration

Title

Subjective measures of stress and arousal

Description

Time Frame

Day 1: 4.5-5.5 hours post drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Susannah Murphy, DPhil

Phone

01865 618313

Ext

+44

susannah.murphy@psych.ox.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Lucy Wright, MSc

Phone

01865 613111

Ext

+44

lucy.wright@psych.ox.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susannah Murphy, DPhil

Organizational Affiliation

University of Oxford

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Oxford

City

Oxford

ZIP/Postal Code

OX3 7JX

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susannah Murphy, DPhil

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

An anonymised dataset will be published as open access data on a secure repository (Open Science Framework https://osf/io/).

IPD Sharing Time Frame

Following full anonymisation of study data and publication of findings. Data will be stored indefinitely.

Links:

URL

http://www.psych.ox.ac.uk/research/psychopharmacology-and-emotion-research-laboratory

Description

PERL Oxford webpage

Learn more about this trial

Citalopram and Stress Reactivity

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