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Predicting Antipsychotic Discontinuation in Psychosis (PADP)

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PET
clinical scale
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring dopamine receptor occupancy, antipsychotics, positron emission tomography

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

patient group

healthy control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Positive and Negative Syndrome Scale(PANSS)Scale
Psychotic symptoms will be assessed by using PANSS 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
Young Mania Rating Scale(YMRS)
Mood symptoms will be assessed by using YMRS 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
Columbia Suicide Severity Rating Scale(C-SSR)
Suicide risk will be assessed by using C-SSR at 0, 2, 4, 6, and 8 wk
Quality of Life Scale(QoL)
QoL will be assessed at 0 , 4 and 8 wk
Adverse effects
Adverse effects will be assessed by using side effect rating scale 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

Full Information

First Posted
August 4, 2016
Last Updated
September 23, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02884518
Brief Title
Predicting Antipsychotic Discontinuation in Psychosis
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
dopamine receptor occupancy, antipsychotics, positron emission tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient group
Arm Type
Experimental
Arm Description
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.
Arm Title
healthy control group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PET
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
clinical scale
Intervention Description
Healthy controls should complete clinical scales at baseline. Patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.
Primary Outcome Measure Information:
Title
Ki(cer) of 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 fluorine(F)]DOPA PET)
Description
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.
Time Frame
Change from Baseline Ki(cer) of [18 fluorine(F)]DOPA PET at 7 weeks and at 8 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale(PANSS)Scale
Description
Psychotic symptoms will be assessed by using PANSS at 0, 2, 4, 6, and 8 wk
Time Frame
at 0, 2, 4, 6, and 8 wk
Title
Brief Psychiatric Rating Scale(BPRS)
Description
Psychotic symptoms will be assessed by using BPRS at 0, 2, 4, 6, and 8 wk
Time Frame
at 0, 2, 4, 6, and 8 wk
Title
Young Mania Rating Scale(YMRS)
Description
Mood symptoms will be assessed by using YMRS at 0, 2, 4, 6 and 8 wk
Time Frame
at 0, 2, 4, 6 and 8 wk
Title
Hamilton Depression Rating Scale(HAM-D)
Description
Mood symptoms will be assessed by using HAM-D at 0, 2, 4, 6 and 8 wk
Time Frame
at 0, 2, 4, 6 and 8 wk
Title
Columbia Suicide Severity Rating Scale(C-SSR)
Description
Suicide risk will be assessed by using C-SSR at 0, 2, 4, 6, and 8 wk
Time Frame
at 0, 2, 4, 6, and 8 wk
Title
Quality of Life Scale(QoL)
Description
QoL will be assessed at 0 , 4 and 8 wk
Time Frame
at 0 , 4 and 8 wk
Title
Adverse effects
Description
Adverse effects will be assessed by using side effect rating scale at 0 and 4 wk
Time Frame
at 0 and 4 wk
Title
Kv-Subjective Well-Being Under Neuroleptics Scale(SWN)-K
Description
Dysphoria will be assessed by using Kv-SWN-K at 0, 4 and 8 wk
Time Frame
at 0, 4 and 8 wk

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Patient group Patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder patients diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for at least 1 year. 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Euitae Kim, Ph. D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Predicting Antipsychotic Discontinuation in Psychosis

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