Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202306
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2005-09-14
Brief Title:
Indicated Prevention of Psychotic Disorders With Low-dose Lithium
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 450mgday 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 ANDOR attenuated psychotic symptoms ANDOR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E01028 | None | None | None |