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Indicated Prevention of Psychotic Disorders With Low-dose Lithium
This study has been completed.
Sponsor:
Melbourne Health
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00202306
First received: September 14, 2005
Last updated: May 28, 2013
Last verified: September 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia Bipolar Disorder Psychotic Disorders | Drug: lithium carbonate | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Melbourne Health:
Primary Outcome Measures:
- Symptomatic improvement
- Cognitive improvement
- Brain structural change (grey matter, ventricle to brain ratio)
- Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)
Secondary Outcome Measures:
- Transition rate to Psychosis
- Quality of life
- serum apoptosis parameters (eg. bcl2)
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2001 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00202306
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202306
Locations
| Australia, Victoria | |
| ORYGEN Youth Health, PACE Clinic | |
| Parkville, Victoria, Australia, 3052 | |
Sponsors and Collaborators
Melbourne Health
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | Gregor E Berger, MD | University of Melbourne, Department of Psychiatry, ORYGEN Research Centre |
More Information
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 |
| Study First Received: | September 14, 2005 |
| Last Updated: | May 28, 2013 |
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 |
ClinicalTrials.gov processed this record on July 21, 2017