Indicated Prevention of Psychotic Disorders With Low-dose Lithium

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202306
• Other study ID #: SMRI 01-038
• Secondary ID: E/01/028
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: May 28, 2013
• Start date: November 2001
• Est. completion date: December 2006

Study information

• Verified date: September 2005
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• lithium carbonate

Locations

Country	Name	City	State
Australia	ORYGEN Youth Health, PACE Clinic	Parkville	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Melbourne Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic improvement
Primary	Cognitive improvement
Primary	Brain structural change (grey matter, ventricle to brain ratio)
Primary	Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)
Secondary	Transition rate to Psychosis
Secondary	Quality of life
Secondary	serum apoptosis parameters (eg. bcl2)

External Links

•   Description of Unit of Neuroprotection in Young People (UNYP)