Antidepressants, Emotions and Personality

NCT01946607 | Completed

• 1 other identifier: 09/H0605/60
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroticism is a personality trait described as an enduring tendency to experience negative emotional states and to respond poorly to environmental stress. It has been shown that high neuroticism can predispose, amongst other factors, to the development of depressive episodes. Recent studies suggest that subjects with high neuroticism have a different response to stimuli with an emotional content, showing both decreased processing of positive or increased processing of negative emotionally salient cues. These differences in cognitive processing of emotional stimuli are believed to underpin the psychological characteristics that link high neuroticism with a higher risk for depression. Preliminary data also indicate that modulation of serotonin function by antidepressant treatment in healthy volunteers with high neuroticism traits could modify the brain activity associated with the processing of emotional stimuli that is dysfunctional in this vulnerable population. The aim of this research is to investigate further whether modulation of serotonin function via administration of serotonergic antidepressants (SSRIs) can revert the dysfunctional emotion processing that characterises subjects with the personality trait of high neuroticism. In particular we hypothesise that SSRI administration will modify the abnormal patterns in attention, physiological reactivity and regulation of emotional stimuli present in healthy individuals with the vulnerable personality trait of high neuroticism. Carrying out this research on healthy volunteers will enable us to understand if modulating serotonin function by antidepressant administration has an effect not only on mood symptoms - as is evident in depressed patients - but also on the predisposing psychological and cognitive processes that sustain the depressed mood, such as the response to emotional stimuli. We will also be able to verify if this effect is shown early treatment and prior to any subjective changes in mood. This will be done by administering seven days of either the antidepressant citalopram or placebo to subjects with high neuroticism scores and then comparing them on a series of computer based psychological tests measuring various aspects of how emotionally salient stimuli are processed.

Conditions

Antidepressive Agents, Second-Generation

Keywords

Neuroticism; Emotion processing; Eye gaze movements; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• Eye gaze fixations over the region of the eyes and whole face region of facial expressions during a gender discrimination task of emotional facial expressions

  Fixations were defined as a set of eye positions within a defined area for a selected amount of time. We adopted the default values defining a fixation to be within a 0.30 x 0.30 degree box for 100 ms and calculating fixations using a velocity/distance algorithm. In the calculation, subjects' eyes are allowed to drift during fixation as long as the amount of drift is less than this area per 100 ms. We calculated the number of fixations present within the Region of Interest (ROI) of the eyes of the facial expressions used as stimuli in the task.

  Day 7 of treatment administration

Secondary Outcomes (8)

• Scanpath length over the eye region and whole face region of facial expressions during a gender discrimination task of emotional facial expressions

  Day 7 of treatment

• Scanning time over the eyes region and whole face of facial expressions during a gender discrimination task of emotional facial expressions

  Day 7 of treatment

• Gaze maintenance over the eyes region and whole face of facial expressions during a gender discrimination task of emotional facial expressions

  Day 7 of treatment

• Accuracy and reaction time of emotional facial expressions recognition during a facial expressions recognition task

  Day 7 of treatment

• Recall and recognition scores and reaction times during a memory task for emotionally valenced self-descriptors

  Day 7 of treatment

Other Outcomes (1)

• Change in waking salivary cortisol levels

  Change from baseline (day 0) to day 7 of treatment

Study Arms (2)

Citalopram

ACTIVE COMPARATOR

20 mg citalopram capsule, 1/ day, after breakfast (approximately 8am), for 7 days

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Placebo capsule 1/ day, after breakfast (approximately 8am), for 7 days

Drug: Placebo

Interventions

Citalopram DRUG

Citalopram

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 - 50 years
• Eysenck Personality Questionnaire Neuroticism scale ≥15/24
• Fluent in English language (in order to understand all study instructions and tasks using verbal stimuli)

You may not qualify if:

• any significant medical condition
• current or past history of psychiatric disorder
• family history of mania
• pregnancy or breastfeeding
• taking any current medication (except the contraceptive pill)
• having taken part in other trials involving psychotropic drug intake in the previous three months

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford, Department of Psychiatry, Warneford Hospital

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Interventions

Citalopram

Intervention Hierarchy (Ancestors)

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

Study Officials

• Martina Di Simplicio, MD

  University of Oxford (at the time of study); MRC Cognition and Brain Sciences unit (current)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 1, 2013
• First Posted: September 19, 2013
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 19, 2013

Record last verified: 2013-09

Locations

GB (1)