Indicated Prevention of Psychotic Disorders With Low-dose Lithium

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Description of Unit of Neuroprotection in Young People (UNYP) 

Publications:

Berger GE, Wood S, McGorry PD. Incipient neurovulnerability and neuroprotection in early psychosis. Psychopharmacol Bull. 2003 Spring;37(2):79-101. Review.

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
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