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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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] 0 0
Secondary ID [2] 0 0
SMRI 01-038
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Bipolar Disorder 0 0
Psychotic Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Mental Health 0 0 0 0
Psychosis and personality disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - lithium carbonate

Treatment: Drugs: lithium carbonate

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Symptomatic improvement
Timepoint [1] 0 0
Primary outcome [2] 0 0
Cognitive improvement
Timepoint [2] 0 0
Primary outcome [3] 0 0
Brain structural change (grey matter, ventricle to brain ratio)
Timepoint [3] 0 0
Primary outcome [4] 0 0
Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Transition rate to Psychosis
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Quality of life
Timepoint [2] 0 0
Secondary outcome [3] 0 0
serum apoptosis parameters (eg. bcl2)
Timepoint [3] 0 0

Key inclusion criteria
- Attenuated psychotic symptoms

- Self-limited brief psychotic episode

- Family History of psychosis and decrease in functioning over last year
Minimum age
15 Years
Maximum age
30 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Organic causes of subthreshold psychotic symptoms (eg. epilepsy)

- More than one week of neuroleptic treatment

Study design
Purpose of the study
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
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ORYGEN Youth Health, PACE Clinic - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Melbourne Health
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Mental Health (NIMH)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
This study investigates the neuroprotective properties of low-dose lithium in young
individuals at ultra-high risk of developping a first psychotic episode. Fourty individuals
having some symptoms of an emerging psychotic disorders (without meeting the threshold for a
full-blown mental illness) will be treated with a low dose of lithium (about a third of the
dose that is usually used to treat acute mania). We will assess the progression of the
conditions of these individuals on a montly bases for a year. We will do behavioural,
cognitive and imaging assessments prior start of the treatment, after three months and one
year. We hope to demonstrate that low dose lithium will stop or even reverse the progression
of disease. We expect that behavioral, cognitive and in vivo brain imaging parameters in
those individuals treated with low dose lithium improve, compared to the monitoring group.
Trial website
Trial related presentations / publications
Berger GE, Wood S, McGorry PD. Incipient neurovulnerability and neuroprotection in early psychosis. Psychopharmacol Bull. 2003 Spring;37(2):79-101. Review.
Public notes

Principal investigator
Name 0 0
Gregor E Berger, MD
Address 0 0
University of Melbourne, Department of Psychiatry, ORYGEN Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications