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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

Condition category

Condition code

Mental Health

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]

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]

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]

Baseline (before interferon treatment) and 6 weeks into interferon treatment

Secondary outcome [1]

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]

baseline and 6 weeks.

Secondary outcome [2]

psychiatric diagnosis, measured by the clinical interview schedule revised.

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

David Telling Charitable Trust

Address [1]

2nd Floor, Dolphin House
Bristol Royal Infirmary
Bristol BS2 8HW

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Bristol

Address [1]

Psychopharmacology Unit,
Level 5, Dorothy Hodgkin Building,
Whitson Street,
Bristol
BS1 3NY

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bath local research ethics committee

Ethics committee address [1]

Room 11, John Apley Building
Research Ethics Office
Royal United Hospital
Combe Park
Bath
BA1 3NG

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

Approval date [1]

04/06/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

David Christmas

Address

Psychopharmacology Unit
Level 5, Dorothy Hodgkin Building,
Whitson Street,
Bristol
BS1 3NY

Country

United Kingdom

Phone

+44-(0)-117-3313178

Fax

david.christmas@bristol.ac.uk

Contact person for scientific queries

Name

David Christmas

Address

Psychopharmacology Unit
Level 5, Dorothy Hodgkin Building,
Whitson Street,
Bristol
BS1 3NY

Country

United Kingdom

Phone

+44-(0)-117-3313178

Fax

david.christmas@bristol.ac.uk

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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