Predicting Antipsychotic Discontinuation in Psychosis

Schizophrenia Clinical Trial

— PADP  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02884518
• Other study ID #: [18F]DOPA PET-1000-1.2
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of Life Scale(QoL)	QoL will be assessed at 0 , 4 and 8 wk	at 0 , 4 and 8 wk
Secondary	Adverse effects	Adverse effects will be assessed by using side effect rating scale at 0 and 4 wk	at 0 and 4 wk
Secondary	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