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Antipsychotic Discontinuation in High-risk Subjects

This study has been withdrawn prior to enrollment.
(administrative reason)
Sponsor:
Information provided by (Responsible Party):
Jun Soo Kwon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01758887
First received: December 27, 2012
Last updated: October 12, 2016
Last verified: October 2016
  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
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antipsychotic Discontinuation in High-risk Subjects

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


Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
Healthy control
patients
clinical high risk subjects for psychosis

Detailed Description:
After the antipsychotic medication discontinuation, we are going to assess the changes of the biological markers
  Eligibility

Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
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
Investigators
Principal Investigator: Jun Soo Kwon, MD PhD Seoul National University College of Medicine
  More Information

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: October 12, 2016
Health Authority: Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on December 02, 2016