Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000525381
Ethics application status
Approved
Date submitted
13/09/2008
Date registered
15/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emotional Processing in Interferon-treated Hepatitis C patients
Scientific title
A study to evaluate the effects of Interferon-alpha treatment on changes in facial recognition tasks in hepatitis C patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression in interferon treatment 3682 0
Condition category
Condition code
Mental Health 3847 3847 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1) Eligable Hepatitis Cpatients patients who are going to be treated with interferon-alpha +/- ribavarin will be observed for changes before and 6 weeks into treatment for changes in recognition of facial expressions, mood, anxiety and anger scales and psychiatric diagnosis. The combined duration of these assessments is approximately 2 hours. In addition a healthy control group will also be observed using the same measures.
2) The duration of the trial is roughly 7 weeks - one assessment one week prior to interferon treatment and one six weeks into treatment. In addition for the duration of interferon treatment (usually six to twelve months) patients will be reassessed for psychiatric diagnosis if the treating team feel there has been the possibility of an emerging psychiatric illness.
Intervention code [1] 3395 0
Not applicable
Comparator / control treatment
Healthy controls will be observed using the same measures as the intervention group. No placebo given.
Control group
Active

Outcomes
Primary outcome [1] 4747 0
Changes in thresholds of recognition of different facial expressions. Proceedure:
For the emotion discrimination task, morphed stimuli continua were created that changed from a neutral face to a full exemplar emotional expression. These sequences were generated from a database of films of actors performing facial expressions in front of a Dalsa DS-25-02M30 colour camera (Benton et al., 2007). The camera captured high definition frames (1920 x 1080 pixels) at 25 Hz. We created six such continua using one male and one female actor, for the expressions of happiness, sadness, and anger.

For each continuum (male and female of happy, sad, and angry) we selected 28 frames (i.e., just over one second) from the video footage that covered the development of each emotional expression from neutral to the full exemplar. We selected 10 key frames from these 28 (i.e., every third frame) which were delineated by marking 172 feature points on easily identifiable facial features (e.g., corner of eyes, outline of lips etc.) using Psychomorph software (Tiddeman, Burt, & Perrett, 2001). The shape information from these delineations was used to create morph sequences of 18 images between each key frame using established techniques (Rowland & Perrett, 1995; Tiddeman, Burt, & Perrett, 2001). This generated a sequence of 172 images that closely follows the actual development of the expression and avoids morph-induced artifacts that may occur when creating morphs between a neutral and a full exemplar emotional expression without considering the time course of expression development.

Each threshold therefore represents a point along a 172 image sequence; the sequence contains a facial expression developing between neutral and the full exemplar emotional expression over a period of 1.12 seconds. There is no particular expectation that, within the 1.12 second window, expression onset or offset occurs at the same time for all actors and their expressions. There is also no expectation that the different expressions should develop at the same rate. In the present task it is therefore meaningless to, for example, directly compare the thresholds obtained for different expressions.

Images were greyscaled, and the edges were blurred to display mean luminance (using Gaussian blur of standard deviation 10 pixels) so that no hard image edges would be present when the images were displayed on the mean luminance background.
Timepoint [1] 4747 0
Baseline (before interferon treatment) and 6 weeks into interferon treatment
Secondary outcome [1] 8020 0
Changes in mood: depression (becks depression inventory and visual analogue scales), anxiety (speilberger state/trait anxiety index, visual analogue scales and panic state inventory), irritability (spielberger state/trait anger expression inventory and visual analogue scales)
Timepoint [1] 8020 0
baseline and 6 weeks.
Secondary outcome [2] 8021 0
psychiatric diagnosis, measured by the clinical interview schedule revised.
Timepoint [2] 8021 0
baseline, six weeks and any further timepoint for the duration of interferon treatment (the duration of interferon treatment is decided by the hepatology clinicians independant of the study. Usually interferon treatment duration is six or twelve months; the criteria for deciding this are based upon the genotype of hepatitis C virus and response to treatment(as measured by plasma viral load).

Eligibility
Key inclusion criteria
Hepatitis C patients.
Receiving interferon treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current mental illness at time of starting interferon treatment including drug and alcohol abuse. Past history of schizophrenia, bipolar affective disorder. Current unstable medical illness, current use of antidepressants.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 1199 0
United Kingdom
State/province [1] 1199 0

Funding & Sponsors
Funding source category [1] 3863 0
Charities/Societies/Foundations
Name [1] 3863 0
David Telling Charitable Trust
Country [1] 3863 0
United Kingdom
Primary sponsor type
Hospital
Name
United Bristol Hospitals
Address
Research and Effectiveness Department
Education Centre
Level 3
Upper Maudlin Street
Bristol BS2 8AE
Country
United Kingdom
Secondary sponsor category [1] 3468 0
None
Name [1] 3468 0
Address [1] 3468 0
Country [1] 3468 0
Other collaborator category [1] 412 0
University
Name [1] 412 0
University of Bristol
Address [1] 412 0
Psychopharmacology Unit,
Level 5, Dorothy Hodgkin Building,
Whitson Street,
Bristol
BS1 3NY
Country [1] 412 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5916 0
Bath local research ethics committee
Ethics committee address [1] 5916 0
Room 11, John Apley Building
Research Ethics Office
Royal United Hospital
Combe Park
Bath
BA1 3NG
Ethics committee country [1] 5916 0
United Kingdom
Date submitted for ethics approval [1] 5916 0
Approval date [1] 5916 0
04/06/2008
Ethics approval number [1] 5916 0
08/H0101/75

Summary
Brief summary
Hepatitis C is a condition that if often treated successfully with interferon. However, interferon treatment is known to cause mood problems, including high rates of depression. One possible reason for this is that interferon is thought to affect the brains serotonin system, which governs mood and other emotional tasks such as recognising facial expressions. To date nobody has studied how the brain functioning of this system changes during interferon treatment. Discovering how interferon causes depression will help us to provide more effective treatment, or prevention, of this for future patients undergoing interferon treatment. It may also help us discover what is happening to the brain in other forms of depression.

The purpose of this study is to measure how the recognition of facial expressions changes with interferon treatment and whether this varies with the levels of tryptophan in your blood (tryptophan is a chemical that the body uses to make serotonin). This will give us a measure of how the brains serotonin system changes during interferon treatment and whether this can be linked to the development of depression. This will be done by a computer program which shows pictures of different facial expressions and asks you to decide what emotion they are displaying.
Patients with hepatitis C treated with interferon will demonstrate measurable changes in facial expression processing. Specifically, there will be a change towards that seen in acute tryptophan depletion and depressive episodes; a decreased ability to detect happy faces and an increased ability to detect sad faces. Secondary hypotheses are: the ability to detect angry faces will increase with interferon treatment and will correlate with the irritability measures; the changes in emotional processing will be accompanied with changes in mood and anxiety, and a measurable decrease in the tryptophan/large neutral amino-acid ratio, rather than an increase in the kynurenine/kynurenic acid ratio. We also predict that those already showing depression-like processing of facial expressions and/or those with lower tryptophan/large neutral amino-acid ratios will be more likely to become depressed during the course of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28926 0
Address 28926 0
Country 28926 0
Phone 28926 0
Fax 28926 0
Email 28926 0
Contact person for public queries
Name 12083 0
David Christmas
Address 12083 0
Psychopharmacology Unit
Level 5, Dorothy Hodgkin Building,
Whitson Street,
Bristol
BS1 3NY
Country 12083 0
United Kingdom
Phone 12083 0
+44-(0)-117-3313178
Fax 12083 0
Email 12083 0
[email protected]
Contact person for scientific queries
Name 3011 0
David Christmas
Address 3011 0
Psychopharmacology Unit
Level 5, Dorothy Hodgkin Building,
Whitson Street,
Bristol
BS1 3NY
Country 3011 0
United Kingdom
Phone 3011 0
+44-(0)-117-3313178
Fax 3011 0
Email 3011 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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