Citalopram and Stress Reactivity

NCT04161209 | Unknown

• 1 other identifier: OCST_Citalopram
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Citalopram; Stress induction paradigm; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Day 1: 4.5-5.5 hours post drug administration

• Salivary cortisol

  Day 1: 4.5-5.5 hours post drug administration

• Blood pressure

  Day 1: 4.5-5.5 hours post drug administration

• Subjective measures of stress and arousal

  Day 1: 4.5-5.5 hours post drug administration

Study Arms (2)

Drug: Citalopram

EXPERIMENTAL

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

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Lactose placebo (tablet encapsulated in opaque capsule)

Other: Placebo

Interventions

Citalopram DRUG

Single dose administration of citalopram (20mg)

Drug: Citalopram

Placebo OTHER

Lactose placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead
• University of Bath: collaborator

Study Sites (1)

University of Oxford

Oxford, OX3 7JX, United Kingdom

RECRUITING

Related Links

• PERL Oxford webpage

MeSH Terms

Conditions

Depression; Depressive Disorder; Mental Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Susannah Murphy, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susannah Murphy, DPhil

CONTACT

01865 618313; susannah.murphy@psych.ox.ac.uk

Lucy Wright, MSc

CONTACT

01865 613111; lucy.wright@psych.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: October 11, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Following full anonymisation of study data and publication of findings. Data will be stored indefinitely.

Locations

GB (1)