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OpenTrials
Completed

NCT Number: NCT01660880

Validation of Receptor Occupancy Simulation

* To estimate dopamine receptor occupancy by aripiprazole using computer simulation * To measure dopamine receptor occupancy by aripiprazole in patients treated with the antipsychotics * To validate the simulation result by comparing the receptor occupancy from the simulation with that from the patients

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Key information

Conditions

Dopamine Receptor Occupancy Medication Satisfaction Mental Disorders Prolactin Level Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical diagnosis of schizophrenia
  • treated with aripiprazole or risperidone
  • no change in dose of antipsychotics for at least 6 weeks
  • total PANSS score should be below 80

Exclusion criteria

  • Other psychiatric disorders rather than schizophrenia
  • history of head trauma
  • positive in urine hCG
  • on antidepressant, anticholinergics or mood stabilizer

Treatment and study plan

Primary outcomes

  1. Dopamine receptor occupancy

    Time frame: 72 hrs after the last administration

    Measured using 11C-raclopride positron emission tomography

Secondary outcomes

  1. Hamilton rating scale for depression

    Time frame: Baseline and 72 hours after the last administration

    HAM-D score

  2. Barnes akathisia scale

    Time frame: Baseline and 72 hours after the last administration

    BAS score

  3. Abnormal involuntary movement scale

    Time frame: Baseline and 72 hours after the last administration

    AIMS score

  4. Simpson-Angus scale

    Time frame: Baseline and 72 hours after the last administration

    SAS score

  5. Treatment satisfaction questionnaire for medication

    Time frame: Baseline and 72 hours after the last administration

    TSQM score

  6. Medication satisfaction questionnaire

    Time frame: Baseline and 72 hours after the last administration

    MSQ score

  7. N-back task

    Time frame: Baseline and 72 hours after the last administration

    To measure the change in working memory performance

  8. Prolactin level

    Time frame: Baseline and 72 hours after the last administration

    To explore the effect of receptor occupancy on the blood prolactin level

  9. Dopamine receptor occupancy

    Time frame: 3 hrs after the last administration

  10. Dopamine receptor occupancy

    Time frame: 24 hrs after the last administration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 9, 2012
Registry last updated
Apr 8, 2019

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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