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Completed

NCT Number: NCT00202306

Indicated Prevention of Psychotic Disorders With Low-dose Lithium

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.

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Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ORYGEN Youth Health, PACE Clinic

Parkville, Victoria, 3052, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lithium Carbonate

Drug

Primary outcomes

  1. Symptomatic improvement

  2. Cognitive improvement

  3. Brain structural change (grey matter, ventricle to brain ratio)

  4. Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)

Secondary outcomes

  1. Transition rate to Psychosis

  2. Quality of life

  3. serum apoptosis parameters (eg. bcl2)

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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