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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12605000254695

Ethics application status

Approved

Date submitted

25/08/2005

Date registered

1/09/2005

Date last updated

8/08/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Indicated Prevention of Psychotic Disorders with Low-dose Lithium

Scientific 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

Secondary ID [1]

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prodrome of schizoprenia

Condition category

Condition code

Mental Health

Schizophrenia

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

450mg lithium carbonate per day One year primary endpoint (three months), secondary endpoint (one year).

Intervention code [1]

Prevention

Comparator / control treatment

no comparator drug; participants received councelling according to the PACE guidelines for the optimal treatment of prodromal patients

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Measurements of the neuroprotective effects of low dose lithium

Timepoint [1]

Measured at 3 and 12 months

Primary outcome [2]

The neuroprotective effects of low dose lithium were assessed using structural and metabolica imaging, as well as T-2 relation time (specification of the primary outcome mentioned above)

Timepoint [2]

Scanning at baseline and 3 months

Secondary outcome [1]

The effect of low dose lithium of neuroprotective proteins.

Timepoint [1]

Measured at 3 and 12 months.

Eligibility

Key inclusion criteria

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.

Minimum age

Not stated

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

No exclusion criteria

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/01/2001

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other

Name [1]

stanley Medical Research Centre

Address [1]

The Stanley Medical Research Institute 8401 Connecticut Avenue, Suite 200 Chevy Chase, MD 20815 phone: 301-571-0760 fax: 301-571-0769 email: [email protected]

Country [1]

United States of America

Primary sponsor type

Charities/Societies/Foundations

Name

stanley Medical Research Centre (USA)

Address

The Stanley Medical Research Institute
8401 Connecticut Avenue, Suite 200
Chevy Chase, MD 20815
phone: 301-571-0760
fax: 301-571-0769
email: [email protected]

Country

United States of America

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

oRYGEN Research Centre

Address [1]

35 Poplar rd. Melbourne, Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Western Mental Health Research & Ethics committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Gregor Berger

Address

ORYGEN Research Centre 35 Poplar Rd Parkville VIC 3052

Country

Australia

Phone

+61 3 93422800

Fax

+61 3 93873003

[email protected]

Contact person for scientific queries

Name

Gregor Berger

Address

ORYGEN Research Centre 35 Poplar Rd Parkville VIC 3052

Country

Australia

Phone

+61 3 93422800

Fax

+61 3 93873003

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically