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Trial registered on ANZCTR


Registration number
ACTRN12609000521224
Ethics application status
Approved
Date submitted
24/06/2009
Date registered
30/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to examine the effectiveness, safety and tolerability of quetiapine in the treatment of anorexia nervosa in young people
Scientific title
Examining the effectiveness, safety and tolerability of 12 weeks of treatment with low-dose quetiapine (100-400 mg/day) in anorexia nervosa patients aged between 15 and 44 years in improving participants' physical and psychological health status
Secondary ID [1] 905 0
Astra Zeneca Protocol ID AU-SEA-0002
TGA CTN number 2003/289
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 237091 0
Condition category
Condition code
Mental Health 237413 237413 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
oral low-dose quetiapine therapy
100-400 mg/day for a total of 12 weeks, together with treatment as usual (cognitive behavioural therapy (CBT), individual, family, and supportive psychotherapy) for 12 weeks.
Intervention code [1] 236808 0
Treatment: Drugs
Comparator / control treatment
treatment as usual only, atypical antipsychotics (including quetiapine) were not permitted
Control group
Active

Outcomes
Primary outcome [1] 238216 0
participants' physical health status (height, weight, blood pressure, heart rate)
Timepoint [1] 238216 0
baseline, weekly for the first 12 weeks, then at 26 and 52 weeks
Primary outcome [2] 238217 0
participants' physical health status (liver, kidney and thyroid function, haematological profile, random blood glucose levels, prolactin levels, acetylated haemoglobin (HbAc1) levels, electrocardiogram (ECG)
Timepoint [2] 238217 0
Baseline, weeks 12, 26 and 52
Secondary outcome [1] 244531 0
Structured Clinical Interview for the Diagnostic and Statistical Manual of Psychiatric Disorders IV (SCID-IV), used for the diagnosis of psychiatric conditions
Timepoint [1] 244531 0
Week 1
Secondary outcome [2] 244532 0
Eating Disorder Examination (EDE)
Timepoint [2] 244532 0
Baseline, weeks 12, 26 and 52
Secondary outcome [3] 244533 0
Psychological symptoms associated with anorexia nervosa as measured by the Eating Disorder Inventory-2 (EDI-2)
Timepoint [3] 244533 0
Baseline, weeks 12, 26 and 52
Secondary outcome [4] 244534 0
Centre for Epidemiologic Studies Depression Scale (CES-D)
Timepoint [4] 244534 0
Baseline, weeks 12, 26 and 52
Secondary outcome [5] 244535 0
Maudsely Assessment of Delusions Scale (MADS)
Timepoint [5] 244535 0
Baseline, weeks 12, 26 and 52
Secondary outcome [6] 244536 0
Mood and Anxiety Symptom Questionnaire (MASQ)
Timepoint [6] 244536 0
Baseline, weeks 12, 26 and 52
Secondary outcome [7] 244537 0
Personal Wellbeing Index
Timepoint [7] 244537 0
Baseline, weeks 12, 26 and 52
Secondary outcome [8] 244538 0
Side effects profiles as measured by the Udvalg for Kliniske Undersogelser (UKU) Side Effects Ratings Scale
Timepoint [8] 244538 0
Baseline, weeks 12, 26 and 52
Secondary outcome [9] 244539 0
Medication Adherence Rating Scale
Timepoint [9] 244539 0
Baseline, weeks 12, 26 and 52

Eligibility
Key inclusion criteria
A Diagnostic and Statistical Manual for Psychiatric Disorders IV (DSM-IV) diagnosis of anorexia nervosa
No history of treatment with an atypical antipsychotic, though treatment for less than 7 days was considered acceptable
Minimum age
15 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment with an atypical antipsychotic drug for longer than 7 days, comorbid psychotic illness, history of brain infarction or brain surgery, diabetes, an intelligence quotient (IQ) of less than 70

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was administered by a Research Fellow at the Orygen Youth Health Research Centre (a separate entity to the Eating Disorders Unit)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were recruited from the Orygen Youth Health Eating Disorders Clinic, the Royal Melbourne Hospital Eating Disorders Clinic and the Melbourne Clinic. Those who gave their informed consent were assigned to either the treatment or control groups using a computer generated randomised sequence, separate for the three recruitment sites, that was generated and administered by a Research Fellow.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
open-label flexible dose range
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237205 0
Commercial sector/Industry
Name [1] 237205 0
Astra Zeneca Australia
Country [1] 237205 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Astra Zeneca Australia
Address
Medical Division
Astra Zeneca Pty Ltd
Alma Rd, North Ryde
NSW 2113
Country
Australia
Secondary sponsor category [1] 4697 0
University
Name [1] 4697 0
Orygen Youth Health Research Centre
Address [1] 4697 0
Locked Bag 10
Parkville
VIC 3052
Country [1] 4697 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239305 0
NorthWestern Mental Health Research and Ethics Committee
Ethics committee address [1] 239305 0
Ethics committee country [1] 239305 0
Australia
Date submitted for ethics approval [1] 239305 0
Approval date [1] 239305 0
01/08/2003
Ethics approval number [1] 239305 0
E/03/029

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29794 0
Address 29794 0
Country 29794 0
Phone 29794 0
Fax 29794 0
Email 29794 0
Contact person for public queries
Name 13041 0
Professor Patrick McGorry
Address 13041 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville
VIC 3052
Country 13041 0
Australia
Phone 13041 0
+61 3 9342 2800
Fax 13041 0
Email 13041 0
pmcgorry@unimelb.edu.au
Contact person for scientific queries
Name 3969 0
Professor Patrick McGorry
Address 3969 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville
VIC 3052
Country 3969 0
Australia
Phone 3969 0
+61 3 9342 2800
Fax 3969 0
Email 3969 0
pmcgorry@unimelb.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.