Predicting Antipsychotic Discontinuation in Psychosis

Seoul National University Hospital35 enrolled

Overview

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.

There are two groups: the healthy control group (n=12) and the patient group (n=26). The patient group recruits subjects diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for 1 year. Participants will complete clinical scales and undergo PET scans. 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 of presynaptic dopamine and relapse in the patients discontinuing treatment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

PETDEVICE

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.

clinical scaleBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Patient group 1. Patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder 2. patients diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for at least 1 year. 3. Patients who have maintained in the stable state for 3 months without medication change at the baseline. 2\. 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 Exclusion Criteria: 1. Participants should not have any neurological illness such as head trauma, seizure and meningitis. 2. Participants should not be diagnosed as Mental retardation(IQ\<70) 3. Participants should not have severe personality disorder, substance abuse or dependence (except for nicotine abuse and dependence) and severe medical conditions.

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Positive and Negative Syndrome Scale(PANSS)Scale

Psychotic symptoms will be assessed by using PANSS at 0, 2, 4, 6, and 8 wk

Time frame: at 0, 2, 4, 6, and 8 wk

Brief Psychiatric Rating Scale(BPRS)

Psychotic symptoms will be assessed by using BPRS at 0, 2, 4, 6, and 8 wk

Time frame: at 0, 2, 4, 6, and 8 wk

Young Mania Rating Scale(YMRS)

Mood symptoms will be assessed by using YMRS at 0, 2, 4, 6 and 8 wk

Time frame: at 0, 2, 4, 6 and 8 wk

Hamilton Depression Rating Scale(HAM-D)

Mood symptoms will be assessed by using HAM-D at 0, 2, 4, 6 and 8 wk

Time frame: at 0, 2, 4, 6 and 8 wk

Columbia Suicide Severity Rating Scale(C-SSR)

Suicide risk will be assessed by using C-SSR at 0, 2, 4, 6, and 8 wk

Time frame: at 0, 2, 4, 6, and 8 wk

Quality of Life Scale(QoL)

QoL will be assessed at 0 , 4 and 8 wk

Data from ClinicalTrials.gov

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