- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202306
Indicated Prevention of Psychotic Disorders With Low-dose Lithium
May 28, 2013 updated by: Melbourne Health
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Parkville, Victoria, Australia, 3052
- ORYGEN Youth Health, PACE Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Attenuated psychotic symptoms
- Self-limited brief psychotic episode
- Family History of psychosis and decrease in functioning over last year
Exclusion Criteria:
- Organic causes of subthreshold psychotic symptoms (eg. epilepsy)
- More than one week of neuroleptic treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Symptomatic improvement
|
Cognitive improvement
|
Brain structural change (grey matter, ventricle to brain ratio)
|
Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)
|
Secondary Outcome Measures
Outcome Measure |
---|
Quality of life
|
Transition rate to Psychosis
|
serum apoptosis parameters (eg. bcl2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregor E Berger, MD, University of Melbourne, Department of Psychiatry, ORYGEN Research Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
May 30, 2013
Last Update Submitted That Met QC Criteria
May 28, 2013
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Mental Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Antimanic Agents
- Lithium Carbonate
Other Study ID Numbers
- SMRI 01-038
- E/01/028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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