Indicated Prevention of Psychotic Disorders With Low-dose Lithium

NCT ID: NCT00202306

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2006-12-31

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.

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.

Conditions

Schizophrenia; Bipolar Disorder; Psychotic Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

lithium carbonate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Melbourne Health

OTHER

Sponsor Role: lead

Responsible Party

ORYGEN Research Centre

Principal Investigators

Gregor E Berger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne, Department of Psychiatry, ORYGEN Research Centre

Locations

ORYGEN Youth Health, PACE Clinic

Parkville, Victoria, Australia

Countries

Australia

References

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

Reference Type: BACKGROUND

PMID: 14566217 (View on PubMed)

Related Links

http://www.ORYGEN.org.au

Description of Unit of Neuroprotection in Young People (UNYP)

Other Identifiers

E/01/028

Identifier Type: -

Identifier Source: secondary_id

SMRI 01-038

Identifier Type: -

Identifier Source: org_study_id