Predicting Antipsychotic Discontinuation in Psychosis (PADP)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Device: PET; Behavioral: clinical scale

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient group; 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.	Device: PET; 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.; Behavioral: clinical scale; Healthy controls should complete clinical scales at baseline. Patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.
Other: healthy control group; 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.	Device: PET; 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.; Behavioral: clinical scale; Healthy controls should complete clinical scales at baseline. Patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: antipsychotics; positron emission tomography; dopamine receptor occupancy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: [18F]DOPA PET-1000-1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED