NCT02248987

Brief Summary

The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity according to the antipsychotic treatment response in schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

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

Study Start

First participant enrolled

May 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

September 22, 2014

Last Update Submit

April 4, 2019

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging.

    within 2 weeks from enrollment

Secondary Outcomes (4)

  • resting state functional magnetic resonance imaging

    within 2 weeks from enrollment

  • diffusion tensor imaging

    within 2 weeks from enrollment

  • clinical measure including Positive and Negative Syndrome Scale

    within 2 weeks from enrollment

  • neurocognitive function test

    within 2 weeks from enrollment

Study Arms (3)

Clozapine

stable patients treated with clozapine

Other: patients treated with antipsychotics

Other antipsychotics

stable patients treated with risperidone or paliperidone or olanzapine

Other: patients treated with antipsychotics

Healthy volunteer

healthy controls

Other: patients treated with antipsychotics

Interventions

patients treated with antipsychoticsOTHER
ClozapineHealthy volunteerOther antipsychotics

Eligibility Criteria

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

1. Schizophrenia patients treated with clozapine 2. Schizophrenia patients treated with risperidone or paliperidone or olanzapine 3. Healthy volunteers

You may qualify if:

  • diagnosis of schizophrenia
  • clinically stable state

You may not qualify if:

  • history of previous head injury, epileptic disorder, other medical comorbidity
  • substance abuse/dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing AgentsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPsychotropic Drugs

Study Design

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

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 25, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

KR(1)