Indicated Prevention of Psychotic Disorders With Low-dose Lithium - Full Text View

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 Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Bipolar Disorder Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

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)

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.

Eligibility


Ages Eligible for Study:	15 Years to 30 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Description of Unit of Neuroprotection in Young People (UNYP) This link exits the ClinicalTrials.gov site

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
Study First Received:	September 14, 2005
Last Updated:	May 28, 2013
Health Authority:	Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council

Keywords provided by Melbourne Health:


at risk mental state prodrome ultra high risk	first episode psychosis schizophrenia bipolar disorder

Additional relevant MeSH terms:


Bipolar Disorder Disease Mental Disorders Psychotic Disorders Schizophrenia	Affective Disorders, Psychotic Mood Disorders Pathologic Processes Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on March 01, 2015