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Trial registered on ANZCTR


Trial ID
ACTRN12605000254695
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
1/09/2005
Date last updated
8/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Indicated Prevention of Psychotic Disorders with Low-dose Lithium
Scientific title
An open-labeled, parallel-group, single-blinded (rater) pilot study to investigate the neuroprotective effects of of low-dose lithium in young subjects at ultra high risk (UHR) of developing a first-episode psychotic disorder
Secondary ID [1] 262964 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prodrome of schizoprenia 341 0
Condition category
Condition code
Mental Health 394 394 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
450mg lithium carbonate per day One year primary endpoint (three months), secondary endpoint (one year).
Intervention code [1] 252 0
Prevention
Comparator / control treatment
no comparator drug; participants received councelling according to the PACE guidelines for the optimal treatment of prodromal patients
Control group
Uncontrolled

Outcomes
Primary outcome [1] 451 0
Measurements of the neuroprotective effects of low dose lithium
Timepoint [1] 451 0
Measured at 3 and 12 months
Primary outcome [2] 287709 0
The neuroprotective effects of low dose lithium were assessed using structural and metabolica imaging, as well as T-2 relation time (specification of the primary outcome mentioned above)
Timepoint [2] 287709 0
Scanning at baseline and 3 months
Secondary outcome [1] 987 0
The effect of low dose lithium of neuroprotective proteins.
Timepoint [1] 987 0
Measured at 3 and 12 months.

Eligibility
Key inclusion criteria
PACE criteria for identifying patients at high risk include subjects with a family history of psychosis and a decrease in functioning (30% GAF) AND/OR attenuated psychotic symptoms AND/OR brief psychotic symptoms (BLIPS) resolving without treatment.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 446 0
Other
Name [1] 446 0
stanley Medical Research Centre
Address [1] 446 0
The Stanley Medical Research Institute
8401 Connecticut Avenue, Suite 200
Chevy Chase, MD 20815
phone: 301-571-0760
fax: 301-571-0769
email: info@stanleyresearch.org
Country [1] 446 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
stanley Medical Research Centre (USA)
Address
The Stanley Medical Research Institute
8401 Connecticut Avenue, Suite 200
Chevy Chase, MD 20815
phone: 301-571-0760
fax: 301-571-0769
email: info@stanleyresearch.org
Country
United States of America
Secondary sponsor category [1] 363 0
Commercial sector/Industry
Name [1] 363 0
oRYGEN Research Centre
Address [1] 363 0
35 Poplar rd. Melbourne, Australia
Country [1] 363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1419 0
North Western Mental Health Research & Ethics committee
Ethics committee address [1] 1419 0
Ethics committee country [1] 1419 0
Australia
Date submitted for ethics approval [1] 1419 0
Approval date [1] 1419 0
Ethics approval number [1] 1419 0

Summary
Brief summary
To investigate whether low-dose lithium is an effective agent in indicated prevention amongst subjects at ultra-high risk of developing a psychotic disorder. This aim will be achieved by treating a high-risk patient population with low-dose lithium (450mg/day) and investigating its effects using clinical, neuropsychological, neuroimaging and cell biological approaches.
We will recruit 30 patients considered to be at ultra-high risk of developing a first psychotic episode, currently receiving treatment at the Personal Assessment and Crisis Evaluation (PACE) clinic in Melbourne, Australia. PACE criteria for identifying patients at high risk include subjects with a family history of psychosis and a decrease in functioning (30% GAF) AND/OR attenuated psychotic symptoms AND/OR brief psychotic symptoms (BLIPS) resolving without treatment. Patients who give informed consent will receive treatment with a slow release form of low dose lithium for a period of a year, plus supportive therapy. Patients who do not consent will receive supportive therapy only. Assessments will be conducted at baseline, twelve weeks and one year post-recruitment. Assessments will include cognitive functioning, structural MRI, 1H-MRS at 3Tesla and cell biological parameters (bcl-2, AP-1; NIMH, Washington DC). In addition, all patients will be seen on a monthly basis for a clinical interview, covering psychopathology, global functioning, and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35110 0
Address 35110 0
Country 35110 0
Phone 35110 0
Fax 35110 0
Email 35110 0
Contact person for public queries
Name 9441 0
Gregor Berger
Address 9441 0
ORYGEN Research Centre
35 Poplar Rd
Parkville VIC 3052
Country 9441 0
Australia
Phone 9441 0
+61 3 93422800
Fax 9441 0
+61 3 93873003
Email 9441 0
gregor@unimelb.edu.au
Contact person for scientific queries
Name 369 0
Gregor Berger
Address 369 0
ORYGEN Research Centre
35 Poplar Rd
Parkville VIC 3052
Country 369 0
Australia
Phone 369 0
+61 3 93422800
Fax 369 0
+61 3 93873003
Email 369 0
bergerg@mac.com