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Trial registered on ANZCTR


Registration number
ACTRN12608000526370
Ethics application status
Approved
Date submitted
12/09/2008
Date registered
15/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep electroencephalogram (EEG) recordings in interferon-alpha treated hepatitis C patients – Pilot Study
Scientific title
A study to evaluate the effects of Interferon-alpha treatment on sleep electroencephalogram (EEG) changes in hepatitis C patients
Secondary ID [1] 714 0
NHS (United Hospitals Bristol) sponsorship and research and development number: ME/2008/2829
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood side effects of interferon alpha treatment 3681 0
Mood effects of interferon treatment of hepatitis C patients 3744 0
Condition category
Condition code
Mental Health 3921 3921 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Mood and brain serotonin functioning changes with interferon treatment in hepatitis C patients.
1) Mood changes will be assessed by: a computerised psychiatric diagnostic programme will also be administered; the CIS-R (Lewis et al., 1992) is a computerised interview schedule that establishes the nature and severity of neurotic symptoms experienced over the previous 7 days and identifies the presence of neurosis. Additional rating scales will be taken. Mood: Beck Depression Inventory (BDI). Anxiety: Spielberger state anxiety inventory (SSAI) and Panic State Inventory (PSI). Irritability: Spielberger state anger expression inventory (STAXI) and Visual Analogue Scales (VAS-each category is measured on 100mm line, anchored from 0: ‘‘not at all’’ to 100: “the most ever”). Sleep: Bristol Sleep Profile, short clinical interview to elicit any sleep disorder.
Brain serotonin functioning will be measured by changes in sleep electroencephalogram architecture: priamary measures are reduced rapid eye movement latency and increased sleep fragmentation. Secondary measures will be: increased rapid eye movement percentage of sleep, reduced stage 2 sleep
2) The study duration will be approximately 7 weeks; one week prior to staring interferon and after six weeks of interferon treatment.Each assessment lasts for approximately 1.5-2hours for the questionnaires and computer programing. The sleep EEG recording runs overnight (approximately 8 hours) for each assessment session. In addition psychiatric diagnosis will be collected for all patients the treating team feel may be suffering from a psychiatric illness for the duration of their interferon treatment (usually six or twelve months).
Intervention code [1] 3393 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4746 0
Sleep EEG changes: Rapid Eye Movement latency and sleep fragmentation
Timepoint [1] 4746 0
Baseline and 6 weeks.
Secondary outcome [1] 8016 0
Mood changes: Depression, Becks Depression Inventory, visual analogue scales.
Timepoint [1] 8016 0
baseline and 6 weeks
Secondary outcome [2] 8017 0
Mood changes: anxiety, speilberger state/trait anxiety inventory, panic state inventory, visual analogue scales
Timepoint [2] 8017 0
Baesline and 6 weeks
Secondary outcome [3] 8018 0
Mood changes: irritability, spielberger state/trait anger expression inventory, visual analogue scales.
Timepoint [3] 8018 0
Baseline and six weeks.
Secondary outcome [4] 8019 0
Psychiatric diagnosis: revised clinical interview schedule (CIS-R), also clinical diagnosis by a study psychiatrist
Timepoint [4] 8019 0
Baseline and week 6. Any timepoint for duration of interferon treatment (the duration of interferon treatment is decided by the treating team independant from the study. It is usually either 6 months or 12 months duration depending upon the genotype of hepatitis C and the early response, measured by plasma viral load, to treatment.

Eligibility
Key inclusion criteria
Hepatitis C, receiving interferon alpha treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current mental illness or drug/alcohol abuse at baseline. History of schizophrenia or bipolar affective disorder. Current unstable medical illness. Taking medicine that affect sleep EEG measures (antidepressants). Current occupational history of nightshift working

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
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] 1198 0
United Kingdom
State/province [1] 1198 0
Bristol

Funding & Sponsors
Funding source category [1] 3861 0
Charities/Societies/Foundations
Name [1] 3861 0
David Telling Charitable trust
Address [1] 3861 0
2nd Floor, Dolphin House
Bristol Royal Infirmary
Bristol BS2 8HW
Country [1] 3861 0
United Kingdom
Funding source category [2] 3862 0
Commercial sector/Industry
Name [2] 3862 0
Schering-Plough
Address [2] 3862 0
Shire Park
Welwyn Garden City
Hertfordshire
AL7 1TW
Country [2] 3862 0
United Kingdom
Primary sponsor type
Hospital
Name
United Hospitals Bristol
Address
Research and Effectiveness Department
Education Centre
Level 3
Upper Maudlin Street
Bristol BS2 8AE
Country
United Kingdom
Secondary sponsor category [1] 3467 0
None
Name [1] 3467 0
Address [1] 3467 0
Country [1] 3467 0
Other collaborator category [1] 411 0
University
Name [1] 411 0
University of Bristol
Address [1] 411 0
Psychopharmacology Unit,
Level 5, Dorothy Hodgkin Building,
Whitson Street,
Bristol
BS1 3NY
Country [1] 411 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5915 0
Bath Local Research Ethics Committee
Ethics committee address [1] 5915 0
Room 11, John Apley Building
Research Ethics Office
Royal United Hospital
Combe Park
Bath
BA1 3NG
Ethics committee country [1] 5915 0
United Kingdom
Date submitted for ethics approval [1] 5915 0
Approval date [1] 5915 0
04/06/2008
Ethics approval number [1] 5915 0
08/H0101/76

Summary
Brief summary
Hepatitis C is a condition that is often treated successfully with interferon. However, interferon treatment can sometimes cause mood problems, including depression. One possible reason for this is that interferon may affect a chemical called serotonin in the brain, which governs mood and sleep. No-one has studied changes in the brain’s serotonin system 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 the brain activity during sleep, before and during interferon treatment. This will give us a measure of how the brain’s serotonin system changes during interferon treatment and whether this can be linked to the development of depression.
Hypothesis: there will be a shorter period until REM (dreaming sleep) and greater sleep fragmentation (more broken sleep) when patient are taking interferon compared to before treatment. Secondary hypothesis: the degree of sleep change will correlate with worsening scores upon mood, anxiety and irritability scales. Further hypothesis: the degree of sleep change may predict later episodes of depression further on in treatment
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28925 0
Address 28925 0
Country 28925 0
Phone 28925 0
Fax 28925 0
Email 28925 0
Contact person for public queries
Name 12082 0
David Christmas
Address 12082 0
Psychopharmacology Unit,
Level 5,
Dorothy Hodgkin Building,
Whitson Street,
Bristol,
BS1 3NY
UK
Country 12082 0
United Kingdom
Phone 12082 0
+44-(0)117-3313178
Fax 12082 0
Email 12082 0
david.christmas@bristol.ac.uk
Contact person for scientific queries
Name 3010 0
David Christmas
Address 3010 0
Psychopharmacology Unit,
Level 5,
Dorothy Hodgkin Building,
Whitson Street,
Bristol,
BS1 3NY
UK
Country 3010 0
United Kingdom
Phone 3010 0
+44-(0)117-3313178
Fax 3010 0
Email 3010 0
david.christmas@bristol.ac.uk

No information has been provided regarding IPD availability
Summary results
No Results