Antipsychotic Discontinuation in High-risk Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jun Soo Kwon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01758887
First received: December 27, 2012
Last updated: May 18, 2013
Last verified: May 2013
  Purpose
  • Would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control?
  • What would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis?
  • What about the dopamine synthesis in recurred clinical high risk subjects for psychosis after the discontinuation?

Condition
Clinical High Risk for Psychosis
Antipsychotic Discontinuation
Presynaptic Dopamine Synthesis
Glutamate Concentration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Presynaptic dopamine synthesis in the striatum [ Time Frame: baseline ] [ Designated as safety issue: No ]
    measured with [18F]DOPA positron emission tomography

  • Glutamate concentration in the frontal lobe [ Time Frame: baseline ] [ Designated as safety issue: No ]
    measured using magnetic resonance spectroscopy

  • Presynaptic dopamine synthesis in the striatum [ Time Frame: 6 months after the baseline ] [ Designated as safety issue: No ]
    measured using [18F]DOPA positron emission tomography

  • Glutamate concentration in the frontal lobe [ Time Frame: 6 months after the baseline ] [ Designated as safety issue: No ]
    measured using magnetic resonance spectroscopy


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy control
clinical high risk subjects for psychosis

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Clinical high risk subjects for psychosis who have been treated with antipsychotic medication so that reach to the remission.

Criteria

Inclusion Criteria:

  • Diagnosed as a clinical High Risk
  • Treated with antipsychotic drugs
  • PSP1-5 (from SIPS criteria) <3 (severity index)for more than 6 months
  • Had not experienced a symptomatic relapse in the 6 months

Exclusion Criteria:

  • Significant abnormality in laboratory tests
  • History of head trauma
  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: NCT01758887

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jun Soo Kwon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01758887     History of Changes
Other Study ID Numbers: H-1207-055-417
Study First Received: December 27, 2012
Last Updated: May 18, 2013
Health Authority: Korea: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014