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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale(PANSS)Scale | Psychotic symptoms will be assessed by using PANSS at 0, 2, 4, 6, and 8 wk | 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 |
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Inclusion Criteria:
1. Patient group
2. Healthy control group
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Euitae Kim, Ph. D. | Seoul National University Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| 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. |
|
| 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 | 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 | 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 | at 0, 2, 4, 6, and 8 wk |
| Quality of Life Scale(QoL) | QoL will be assessed at 0 , 4 and 8 wk | at 0 , 4 and 8 wk |
| Adverse effects | Adverse effects will be assessed by using side effect rating scale at 0 and 4 wk | at 0 and 4 wk |
| Kv-Subjective Well-Being Under Neuroleptics Scale(SWN)-K | Dysphoria will be assessed by using Kv-SWN-K at 0, 4 and 8 wk | at 0, 4 and 8 wk |