Indicated Prevention of Psychotic Disorders With Low-dose Lithium
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
2 other identifiers
interventional
30
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 schizophrenia
Started Nov 2001
Longer than P75 for phase_4 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMay 30, 2013
September 1, 2005
5.1 years
September 14, 2005
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Symptomatic improvement
Cognitive improvement
Brain structural change (grey matter, ventricle to brain ratio)
Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)
Secondary Outcomes (3)
Transition rate to Psychosis
Quality of life
serum apoptosis parameters (eg. bcl2)
Interventions
Eligibility Criteria
You may qualify if:
- Attenuated psychotic symptoms
- Self-limited brief psychotic episode
- Family History of psychosis and decrease in functioning over last year
You may not qualify if:
- Organic causes of subthreshold psychotic symptoms (eg. epilepsy)
- More than one week of neuroleptic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melbourne Healthlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
ORYGEN Youth Health, PACE Clinic
Parkville, Victoria, 3052, Australia
Related Publications (1)
Berger GE, Wood S, McGorry PD. Incipient neurovulnerability and neuroprotection in early psychosis. Psychopharmacol Bull. 2003 Spring;37(2):79-101.
PMID: 14566217BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregor E Berger, MD
University of Melbourne, Department of Psychiatry, ORYGEN Research Centre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 20, 2005
Study Start
November 1, 2001
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
May 30, 2013
Record last verified: 2005-09