Predicting Antipsychotic Discontinuation in Psychosis
- Conditions
- Schizophrenia
- Interventions
- Device: PETBehavioral: clinical scale
- Registration Number
- NCT02884518
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
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Patient group
-
Patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder
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patients diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for at least 1 year.
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Patients who have maintained in the stable state for 3 months without medication change at the baseline.
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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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description healthy control group clinical scale 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. healthy control group PET 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. patient group PET 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. patient group clinical scale 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.
- Primary Outcome Measures
Name Time Method Ki(cer) of 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 fluorine(F)]DOPA PET) Change from Baseline Ki(cer) of [18 fluorine(F)]DOPA PET at 7 weeks and at 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale(PANSS)Scale at 0, 2, 4, 6, and 8 wk Psychotic symptoms will be assessed by using PANSS at 0, 2, 4, 6, and 8 wk
Brief Psychiatric Rating Scale(BPRS) at 0, 2, 4, 6, and 8 wk Psychotic symptoms will be assessed by using BPRS at 0, 2, 4, 6, and 8 wk
Young Mania Rating Scale(YMRS) at 0, 2, 4, 6 and 8 wk Mood symptoms will be assessed by using YMRS at 0, 2, 4, 6 and 8 wk
Columbia Suicide Severity Rating Scale(C-SSR) at 0, 2, 4, 6, and 8 wk Suicide risk will be assessed by using C-SSR at 0, 2, 4, 6, and 8 wk
Hamilton Depression Rating Scale(HAM-D) at 0, 2, 4, 6 and 8 wk Mood symptoms will be assessed by using HAM-D at 0, 2, 4, 6 and 8 wk
Kv-Subjective Well-Being Under Neuroleptics Scale(SWN)-K at 0, 4 and 8 wk Dysphoria will be assessed by using Kv-SWN-K at 0, 4 and 8 wk
Quality of Life Scale(QoL) at 0 , 4 and 8 wk QoL will be assessed at 0 , 4 and 8 wk
Adverse effects at 0 and 4 wk Adverse effects will be assessed by using side effect rating scale at 0 and 4 wk
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of