Clinical trial NCT02884518: Predicting Antipsychotic Discontinuation in Psychosis
Official title: Predicting Successful Antipsychotic Discontinuation in the First Episode Psychosis by Using Positron Emission Tomography(PET) withPositron Emission Tomography With 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 Fluorine(F)]DOPA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: dopamine receptor occupancy
antipsychotics
positron emission tomography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ki(cer) of 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 fluorine(F)]DOPA PET)
timeFrame: Change from Baseline Ki(cer) of [18 fluorine(F)]DOPA PET at 7 weeks and at 8 weeks
Secondary outcomes:
measure: Positive and Negative Syndrome Scale(PANSS)Scale
timeFrame: at 0, 2, 4, 6, and 8 wk
measure: Brief Psychiatric Rating Scale(BPRS)
timeFrame: at 0, 2, 4, 6, and 8 wk
measure: Young Mania Rating Scale(YMRS)
timeFrame: at 0, 2, 4, 6 and 8 wk
measure: Hamilton Depression Rating Scale(HAM-D)
timeFrame: at 0, 2, 4, 6 and 8 wk
measure: Columbia Suicide Severity Rating Scale(C-SSR)
timeFrame: at 0, 2, 4, 6, and 8 wk
measure: Quality of Life Scale(QoL)
timeFrame: at 0 , 4 and 8 wk
measure: Adverse effects
timeFrame: at 0 and 4 wk
measure: Kv-Subjective Well-Being Under Neuroleptics Scale(SWN)-K
timeFrame: at 0, 4 and 8 wk
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Euitae Kim, Ph. D.
role: STUDY_CHAIR
References: