Status:

COMPLETED

Minimizing Doses of Antipsychotic Medication in Older Patients With Schizophrenia.

Lead Sponsor:

Centre for Addiction and Mental Health

Conditions:

Schizophrenia

Schizoaffective Disorder

Eligibility:

All Genders

50+ years

Phase:

NA

Brief Summary

Since side effects of antipsychotics, dopamine D2 receptor blockers, frequently occur in older patients with schizophrenia and the risk is dose dependent, clinical guidelines universally advocate the ...

Detailed Description

Antipsychotics play a central role in the treatment of schizophrenia irrespective of a patient's age. Aging is associated with an increased sensitivity to drug adverse effects, including adverse effec...

Eligibility Criteria

Inclusion

  • Age of 50 and older
  • DSM-IV/SCID diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic disorder NOS
  • Having been treated with oral risperidone at a steady dose of ≥ 2 mg/day, or with olanzapine at a steady dose of ≥10 mg/day, for at least 12 months.

Exclusion

  • Incapacity to provide consent to psychiatric treatment
  • Participation in this study would result in exceeding the annual radiation dose limits (20 mSv) for human subjects participating in research studies.
  • Substance abuse or dependence (within past six months)
  • Positive urine drug screen
  • Positive serum pregnancy test at screening or positive urine pregnancy test before PET scan
  • Having taken more than one dose of antipsychotics other than risperidone or olanzapine during the 7 days preceding the PET scan
  • History of treatment with long-acting (depot) neuroleptic antipsychotic medication or Risperdal Consta within 12 months of PET scanning
  • Metal implants or a pace-maker that would preclude the MRI scan
  • Addition of or change in dose of antidepressants, valproic acid, lithium, carbamazepine, or lamotrigine for mental health reasons within 12 months of screening
  • History of head trauma resulting in loss of consciousness \> 30 minutes that required medical attention
  • Unstable physical illness or significant neurological disorder including a seizure disorder
  • Size of head, neck, and body being unable to fit PET and MRI scanners
  • Refusal to give consent to investigator to communicate with physician of record for the entire duration of the study
  • Psychiatric concerns raised by the physician of record regarding participation in the study.

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2015

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00716755

Start Date

October 1 2009

End Date

August 1 2015

Last Update

June 6 2022

Active Locations (1)

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1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M5T 1R8