Schizophrenia
Conditions
Keywords
dopamine receptor occupancy, antipsychotics, positron emission tomography
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.
Interventions
DEVICEPET
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.
BEHAVIORALclinical scale
Healthy controls should complete clinical scales at baseline. Patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed