Antipsychotic Discontinuation in High-risk Subjects

NCT01758887 | Withdrawn

• 1 other identifier: H-1207-055-417
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

• 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?

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Presynaptic dopamine synthesis in the striatum

  measured with \[18F\]DOPA positron emission tomography

  baseline

Study Arms (2)

Controls

Healthy control

patients

clinical high risk subjects for psychosis

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Significant abnormality in laboratory tests
• History of head trauma

Sponsors & Collaborators

• Seoul National University Hospital: lead

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 Disorders; Mental Disorders

Study Officials

• Jun Soo Kwon, MD PhD

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)