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Trial record 38 of 595 for:    ESCITALOPRAM

Citalopram and Stress Reactivity

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ClinicalTrials.gov Identifier: NCT04161209
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
University of Bath
Information provided by (Responsible Party):
drsusannahmurphy, University of Oxford

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 disease Intervention/treatment Phase
Depression Depressive Disorder Mental Disorder Antidepressive Agents Cognition Stress Drug: Citalopram Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : October 11, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Heart rate variability (Root Mean Square Of Successive Differences: RMSSD) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161209


Contacts
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Contact: Susannah Murphy, DPhil 01865 618313 ext +44 susannah.murphy@psych.ox.ac.uk
Contact: Lucy Wright, MSc 01865 613111 ext +44 lucy.wright@psych.ox.ac.uk

Locations
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United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 7JX
Contact: Susannah Murphy, DPhil         
Sponsors and Collaborators
University of Oxford
University of Bath
Investigators
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Principal Investigator: Susannah Murphy, DPhil University of Oxford

Additional Information:
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Responsible Party: drsusannahmurphy, Senior Research Fellow, University of Oxford
ClinicalTrials.gov Identifier: NCT04161209     History of Changes
Other Study ID Numbers: OCST_Citalopram
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: An anonymised dataset will be published as open access data on a secure repository (Open Science Framework https://osf/io/).
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Following full anonymisation of study data and publication of findings. Data will be stored indefinitely.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by drsusannahmurphy, University of Oxford:
Citalopram
Stress induction paradigm
Healthy volunteers
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Disease
Depressive Disorder
Mental Disorders
Pathologic Processes
Mood Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents