Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00202306




Registration number
NCT00202306
Ethics application status
Date submitted
14/09/2005
Date registered
20/09/2005
Date last updated
30/05/2013

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
E/01/028
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
Schizophrenia
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Organic causes of subthreshold psychotic symptoms (eg. epilepsy)
* More than one week of neuroleptic treatment

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ORYGEN Youth Health, PACE Clinic - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
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

Summary
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
https://clinicaltrials.gov/study/NCT00202306
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.
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00202306