Indicated Prevention of Psychotic Disorders With Low-dose Lithium
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ClinicalTrials.gov Identifier: NCT00202306 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: May 30, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Bipolar Disorder Psychotic Disorders | Drug: lithium carbonate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | November 2001 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |
- Symptomatic improvement
- Cognitive improvement
- Brain structural change (grey matter, ventricle to brain ratio)
- Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)
- Transition rate to Psychosis
- Quality of life
- serum apoptosis parameters (eg. bcl2)

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Ages Eligible for Study: | 15 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202306
Australia, Victoria | |
ORYGEN Youth Health, PACE Clinic | |
Parkville, Victoria, Australia, 3052 |
Principal Investigator: | Gregor E Berger, MD | University of Melbourne, Department of Psychiatry, ORYGEN Research Centre |
Additional Information:
Publications:
Responsible Party: | Gregor Berger MD, Senior Lecturer, ORYGEN Research Centre |
ClinicalTrials.gov Identifier: | NCT00202306 History of Changes |
Other Study ID Numbers: |
SMRI 01-038 E/01/028 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | May 30, 2013 |
Last Verified: | September 2005 |
Keywords provided by Melbourne Health:
at risk mental state prodrome ultra high risk |
first episode psychosis schizophrenia bipolar disorder |
Additional relevant MeSH terms:
Disease Schizophrenia Bipolar Disorder Mental Disorders Psychotic Disorders Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Bipolar and Related Disorders Lithium Carbonate |
Antidepressive Agents Psychotropic Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |