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Indicated Prevention of Psychotic Disorders With Low-dose Lithium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202306
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 30, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Melbourne Health

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Psychotic Disorders Drug: lithium carbonate Phase 4

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.

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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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Symptomatic improvement
  2. Cognitive improvement
  3. Brain structural change (grey matter, ventricle to brain ratio)
  4. Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)

Secondary Outcome Measures :
  1. Transition rate to Psychosis
  2. Quality of life
  3. serum apoptosis parameters (eg. bcl2)

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00202306

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Australia, Victoria
ORYGEN Youth Health, PACE Clinic
Parkville, Victoria, Australia, 3052
Sponsors and Collaborators
Melbourne Health
National Institute of Mental Health (NIMH)
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Principal Investigator: Gregor E Berger, MD University of Melbourne, Department of Psychiatry, ORYGEN Research Centre
Additional Information:
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Responsible Party: Gregor Berger MD, Senior Lecturer, ORYGEN Research Centre Identifier: NCT00202306    
Other Study ID Numbers: SMRI 01-038
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
ultra high risk
first episode psychosis
bipolar disorder
Additional relevant MeSH terms:
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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