Citalopram and Self Emotional Processing

NCT04169230 | Unknown

• 1 other identifier: Acute_Citalopram
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the effect of an acute dose of citalopram on emotional processing about the self. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of citalopram or placebo. Participants will then complete a number of widely used computer-based cognitive tasks measuring emotional processing biases towards the self. This study has also been registered on OSF: https://osf.io/nhjvs/?view\_only=b39c49bddfd543b99b627dc992e49b45

Conditions

Molecular Mechanisms of Pharmacological Action; Depression; Depressive Disorder; Mental Disorder; Antidepressive Agents; Cognition

Keywords

Citalopram; Emotional Processing; Antidepressants; Self Processing; Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Social Evaluation Learning Task: Bias Scores

  An overall index of positive or negative bias will be calculated for each referential condition (self, friend, stranger) using errors to criterion (the number of errors made before 8 rule-congruent responses). Bias is calculated by subtracting errors to criterion made when learning the dislike rule from errors to criterion made when learning the like rule. A positive value indicates a negative bias, as fewer errors are made learning the dislike rule compared to the like rule. Conversely, a negative value indicates a positive bias, as fewer errors are made learning the like rule compared to the dislike rule. The minimum possible value is - 24 (complete bias towards being liked), and the maximum value is + 24 (complete bias towards being disliked).

  Day 1: 3-5.5 hours post drug administration

• Associative Learning Task: Reaction Times (ms)

  Mean reaction times will be calculated for each referential condition (self, friend, stranger), reward condition (high, medium, low) and valence condition (positive, neutral, negative) for each respective task.

  Day 1: 3-5.5 hours post drug administration

• Associative Learning Task: Accuracy (% correct)

  Mean accuracy will be calculated for each referential condition (self, friend, stranger), reward condition (high, medium, low) and valence condition (positive, neutral, negative) for each respective task.

  Day 1: 3-5.5 hours post drug administration

• Self-Esteem Go/No-Go Association Task: d'

  Discriminative accuracy (d') will be calculated through applying Z-score transformations, and subtracting hit z-scores from false alarm z-scores. Z-scores are adjusted by adding or subtracting .005 if hit or false-alarm rates are 0 or 1. d' -values can then be compared for each possible categorical combination to examine implicit self-biases.

  Day 1: 3-5.5 hours post drug administration

Secondary Outcomes (5)

• Prisoner's Dilemma: Cooperative Behaviours (%)

  Day 1: 3-5.5 hours post drug administration

• Prisoner's Dilemma: Reaction Times (ms)

  Day 1: 3-5.5 hours post drug administration

• Emotional Categorisation and Recall: Number of words categorised

  Day 1: 3-5.5 hours post drug administration

• Emotional Categorisation and Recall: Hits

  Day 1: 3-5.5 hours post drug administration

• Emotional Categorisation and Recall: False Alarms

  Day 1: 3-5.5 hours post drug administration

Study Arms (2)

Citalopram

EXPERIMENTAL

Single acute oral dose 20 mg Citalopram (tablet encapsulated in opaque capsule)

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Single acute oral dose Lactose Placebo (tablet encapsulated in opaque capsule)

Drug: Placebo oral tablet

Interventions

Citalopram DRUG

Single dose administration of citalopram (20mg)

Citalopram

Placebo oral tablet DRUG

Single dose administration 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)
• Current or past history of drug or alcohol dependency
• History of current significant neurological condition (e.g. epilepsy)
• 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

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

• Catherine Harmer, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Katherine S Button, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Hobbs, MSc

CONTACT

01865618335; c.hobbs@bath.ac.uk

Susannah Murphy, DPhil

CONTACT

01865 618313; susannah.murphy@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: SPONSOR

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, but rather using it as a probe to understand the role of serotonin in self-referential emotional processing biases.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 19, 2019
• Study Start: October 11, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: An anonymised dataset will be shared after full anonymisation of study data and publication of findings. Data will be available indefinitely.

Locations

GB (1)