NCT01660880

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

July 23, 2012

Last Update Submit

April 4, 2019

Conditions

Dopamine Receptor OccupancyMedication SatisfactionProlactin LevelSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Dopamine receptor occupancy

    Measured using 11C-raclopride positron emission tomography

    72 hrs after the last administration

Secondary Outcomes (10)

  • Hamilton rating scale for depression

    Baseline and 72 hours after the last administration

  • Barnes akathisia scale

    Baseline and 72 hours after the last administration

  • Abnormal involuntary movement scale

    Baseline and 72 hours after the last administration

  • Simpson-Angus scale

    Baseline and 72 hours after the last administration

  • Treatment satisfaction questionnaire for medication

    Baseline and 72 hours after the last administration

  • +5 more secondary outcomes

Study Arms (1)

aripiprazole

Patient group who is treated with aripiprazole

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with schizophrenia who is in the steady sate of antipsychotic treatment

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jun Soo Kwon, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2012

First Posted

August 9, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

KR(1)