Indicated Prevention of Psychotic Disorders With Low-dose Lithium

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00202306
First received: September 14, 2005
Last updated: May 28, 2013
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Drug: lithium carbonate
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Symptomatic improvement
  • Cognitive improvement
  • Brain structural change (grey matter, ventricle to brain ratio)
  • Brain metabolic changes (Proton Magnetic Resonance Spectroscopy)

Secondary Outcome Measures:
  • Transition rate to Psychosis
  • Quality of life
  • serum apoptosis parameters (eg. bcl2)

Estimated Enrollment: 30
Study Start Date: November 2001
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202306

Locations
Australia, Victoria
ORYGEN Youth Health, PACE Clinic
Parkville, Victoria, Australia, 3052
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Gregor E Berger, MD University of Melbourne, Department of Psychiatry, ORYGEN Research Centre
  More Information

Additional Information:
Publications:
Responsible Party: Gregor Berger MD, Senior Lecturer, ORYGEN Research Centre
ClinicalTrials.gov Identifier: NCT00202306     History of Changes
Other Study ID Numbers: SMRI 01-038, E/01/028
Study First Received: September 14, 2005
Last Updated: May 28, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Melbourne Health:
at risk mental state
prodrome
ultra high risk
first episode psychosis
schizophrenia
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014