ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Receptor Occupancy Simulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01660880
Recruitment Status : Unknown
Verified May 2013 by Jun Soo Kwon, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 9, 2012
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Jun Soo Kwon, Seoul National University Hospital

Brief Summary:
  • 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

Condition or disease
Dopamine Receptor Occupancy Medication Satisfaction Prolactin Level Schizophrenia

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Group/Cohort
aripiprazole
Patient group who is treated with aripiprazole



Primary Outcome Measures :
  1. Dopamine receptor occupancy [ Time Frame: 72 hrs after the last administration ]
    Measured using 11C-raclopride positron emission tomography


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with schizophrenia who is in the steady sate of antipsychotic treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660880


Contacts
Contact: Euitae Kim, M.D., Ph.D. 82-10-9419-1058 euitae.kim@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Euitae Kim, M.D., Ph.D.    82-10-9419-1058    euitae.kim@gmail.com   
Sub-Investigator: Euitae Kim, M.D., Ph.D.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jun Soo Kwon, M.D., Ph.D. Seoul National University Hospital

Responsible Party: Jun Soo Kwon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01660880     History of Changes
Other Study ID Numbers: C-1205-094-410
A070001 ( Other Grant/Funding Number: The Korean Healthcare Technology R&D Project )
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs