Predicting Antipsychotic Discontinuation in Psychosis

NCT02884518 | Unknown DMC

• 1 other identifier: [18F]DOPA PET-1000-1.2
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether dopamine synthesis capacity by using \[18 fluorine(F)\]-DOPA PET for patients with schizophrenia in the maintenance phase can predict treatment discontinuation.

Conditions

Schizophrenia

Keywords

dopamine receptor occupancy; antipsychotics; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• Ki(cer) of 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 fluorine(F)]DOPA PET)

  Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the six-week period in which they will also undergo PET imaging at the baseline and six-week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.

  Change from Baseline Ki(cer) of [18 fluorine(F)]DOPA PET at 7 weeks and at 8 weeks

Secondary Outcomes (8)

• Positive and Negative Syndrome Scale(PANSS)Scale

  at 0, 2, 4, 6, and 8 wk

• Brief Psychiatric Rating Scale(BPRS)

  at 0, 2, 4, 6, and 8 wk

• Young Mania Rating Scale(YMRS)

  at 0, 2, 4, 6 and 8 wk

• Hamilton Depression Rating Scale(HAM-D)

  at 0, 2, 4, 6 and 8 wk

• Columbia Suicide Severity Rating Scale(C-SSR)

  at 0, 2, 4, 6, and 8 wk

Study Arms (2)

patient group

EXPERIMENTAL

The patient group recruits subjects diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for 1 year. Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they will also undergo PET imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity. And patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.

Device: PET; Behavioral: clinical scale

healthy control group

OTHER

Screening tests for healthy volunteers included physical examination, vital signs, laboratory will test (hematology, blood chemistry, and urinalysis), and a 12-lead electrocardiograms. A psychiatric interview with the Structured Clinical Interview for text revision of the Diagnostic and Statistical Manual of Mental Disorders -IV(DSM-IV-TR) Axis I disorders, Research Version, Nonpatient Edition (SCID-I/NP) (First et al. 2002) will be conducted. Subjects with any medically significant abnormality on investigations and/or psychiatric disease will be excluded. Also, healthy control group will take a PET scan at 0, 2, 4, 6, and 8 week and clinical scales at baseline.

Device: PET; Behavioral: clinical scale

Interventions

PET DEVICE

Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they and healthy controls will also undergo PET imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.

healthy control group; patient group

clinical scale BEHAVIORAL

Healthy controls should complete clinical scales at baseline. Patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.

healthy control group; patient group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patient group
• Patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder
• patients diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for at least 1 year.
• Patients who have maintained in the stable state for 3 months without medication change at the baseline.
• \. Healthy control group
• Healthy controls has no Axis I disorder and do not report any past event of neurological or psychiatric illness assessed by the Structured Clinical Interview for DSM Disorders

You may not qualify if:

• Participants should not have any neurological illness such as head trauma, seizure and meningitis.
• Participants should not be diagnosed as Mental retardation(IQ\<70)
• Participants should not have severe personality disorder, substance abuse or dependence (except for nicotine abuse and dependence) and severe medical conditions.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Euitae Kim, Ph. D.

  Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 31, 2016
• Study Start: October 4, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

KR (1)