Depression Clinical Trial
Official title:
The Effect of Acute Citalopram on Self-referential Emotional Processing and Social Cognition in Healthy Volunteers
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
Status | Recruiting |
Enrollment | 44 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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) - 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | University of Bath |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Prisoner's Dilemma: Cooperative Behaviours (%) | The main outcome for this task is the proportion of rounds on which participants choose to cooperate. The conditional probability of cooperating will be calculated according to the proportion of rounds on which participants cooperated following each of the four possible outcomes. | Day 1: 3-5.5 hours post drug administration | |
Secondary | Prisoner's Dilemma: Reaction Times (ms) | Reaction times for cooperation versus non-cooperation choices will be calculated. | Day 1: 3-5.5 hours post drug administration | |
Secondary | Emotional Categorisation and Recall: Number of words categorised | The mean number of positive and negative words categorised as describing or not describing the participant/the other will be recorded. | Day 1: 3-5.5 hours post drug administration | |
Secondary | Emotional Categorisation and Recall: Hits | Mean hits will be collected for each referential condition and valence. | Day 1: 3-5.5 hours post drug administration | |
Secondary | Emotional Categorisation and Recall: False Alarms | Mean alse intrusions will be collected for each referential condition and valence. | Day 1: 3-5.5 hours post drug administration |
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