Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000682943
Ethics application status
Approved
Date submitted
28/06/2011
Date registered
6/07/2011
Date last updated
21/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Serum Brain Derived Neurotrophic Factor (BDNF) and cytokines in quetiapine treated psychosis
Scientific title
Serum BDNF and cytokines in quetiapine treated first episode psychosis.
Secondary ID [1] 262506 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First episode psychosis 268187 0
Condition category
Condition code
Mental Health 268315 268315 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We seek to determine BDNF and cytokine levels in the serum of 19 drug-naive subjects with psychosis, before and after three months of treatment with quetiapine (an antipsychotic), as markers of neurotrophin activity and autoimmunity respectively, and compare with 19 age and sex matched healthy controls. The serum samples are from 19 subjects recruited from a first-episode cohort treated for three months with quetiapine during a dose-finding study at Orygen Youth Health, Parkville, Vic (AU-SEA-0003/ NHMRC 209 062) between 2004 and 2009.
Intervention code [1] 266854 0
Not applicable
Comparator / control treatment
19 age and sex matched healthy controls
Control group
Active

Outcomes
Primary outcome [1] 269069 0
BDNF serum levels at baseline and after three months treatment with quetiapine
Timepoint [1] 269069 0
serum collected at baseline (before quetiapine is first prescribed) and three months aftwer quetiapine treatment, all samples already collected. We estimate analysis of samples will take 10 months
Primary outcome [2] 269070 0
T1 cytokine levels at baseline and after three months treatment with quetiapine
Timepoint [2] 269070 0
serum collected at baseline (before quetiapine is first prescribed) and three months aftwer quetiapine treatment, all samples already collected. We estimate analysis of samples will take 10 months
Primary outcome [3] 290736 0
There has been no exploration of VEGF in schizophrenia or other psychoses. VEGF is one of the cytokines we sought to measure:
We seek to determine BDNF and cytokine levels in the serum of 19 drug-naive subjects with psychosis, before and after three months of treatment with quetiapine (an antipsychotic), as markers of neurotrophin activity and autoimmunity respectively, and compare with 19 age and sex matched healthy controls. The serum samples are from 19 subjects recruited from a first-episode cohort treated for three months with quetiapine during a dose-finding study at Orygen Youth Health, Parkville, Vic (AU-SEA-0003/ NHMRC 209 062) between 2004 and 2009.
Timepoint [3] 290736 0
We hypothesised that baseline subjects would have lower VEGF levels than healthy controls, which would increase following quetiapine treatment. We also hypothesized that changes to VEGF levels would be negatively correlated to a number of outcome measures. Finally, we proposed that there would be a positive correlation between BDNF and VEGF levels.
We seek to determine BDNF and cytokine levels (including VEGF) in the serum of 19 drug-naive subjects with psychosis, before and after three months of treatment with quetiapine (an antipsychotic), as markers of neurotrophin activity and autoimmunity respectively, and compare with 19 age and sex matched healthy controls.
Secondary outcome [1] 276895 0
Any change in BDNF and cytokine over time may correlate with quetiapine dose and with symptom ratings pre and post treatment (Correlation of BDNF and cytokines to clinical outcome)
Timepoint [1] 276895 0
serum collected at baseline (before quetiapine is first prescribed) and three months aftwer quetiapine treatment, all samples already collected. We estimate analysis of samples will take 10 months

Eligibility
Key inclusion criteria
For inclusion in the study patients must fulfil all of the following criteria:
1. Provision of written informed consent prior to any study specific procedures
2. A diagnosis of first-episode psychosis
Minimum age
18 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any of the following is regarded as a criterion for exclusion from the study:
1. Subject returns form to withdraw consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
1/06/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267329 0
Commercial sector/Industry
Name [1] 267329 0
AstraZeneca Pty Ltd
Country [1] 267329 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
145 Cleeland Street, Dandenong, Victoria, 3175
Country
Australia
Secondary sponsor category [1] 266394 0
None
Name [1] 266394 0
Address [1] 266394 0
Country [1] 266394 0
Other collaborator category [1] 252081 0
University
Name [1] 252081 0
Howard Florey Institute
Address [1] 252081 0
Melbourne University, Parkville, Victoria, 3052
Country [1] 252081 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269314 0
Southern Health HREC Monash Medical Centre, 246 Clayton Road Clayton, Victoria, 3168
Ethics committee address [1] 269314 0
Ethics committee country [1] 269314 0
Australia
Date submitted for ethics approval [1] 269314 0
Approval date [1] 269314 0
18/02/2011
Ethics approval number [1] 269314 0
11044L

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

Contacts
Principal investigator
Name 32806 0
A/Prof Brendan Murphy
Address 32806 0
Southern Health Mental Health Service
145 Cleeland Street, Dandenong, Victoria, 3175
Country 32806 0
Australia
Phone 32806 0
+ 61 3 9767 8222
Fax 32806 0
Email 32806 0
[email protected]
Contact person for public queries
Name 16053 0
Brendan Murphy
Address 16053 0
145 Cleeland Street, Dandenong, Victoria, 3175
Country 16053 0
Australia
Phone 16053 0
+ 61 3 9767 8222
Fax 16053 0
Email 16053 0
[email protected]
Contact person for scientific queries
Name 6981 0
Brendan Murphy
Address 6981 0
145 Cleeland Street, Dandenong, Victoria, 3175
Country 6981 0
Australia
Phone 6981 0
+61 3 9767 8222
Fax 6981 0
Email 6981 0
[email protected]

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.