[18 Fluorine(F)]DOPA Determinants and Predictors of Treatment Response in Psychosis

NCT02880995 | Unknown DMC

• 1 other identifier: DOPAPET_predictor-1000
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

The first purpose of this study is to determine if dopamine synthesis capacity is significantly lower in treatment non-responders from illness onset relative to treatment responders. And the second purpose of this study is to determine the potential of \[18 fluorine(F)\]-DOPA to be used to predict treatment response to antipsychotic treatment in first episode psychosis.

Conditions

Schizophrenia

Keywords

dopamine receptor occupancy; antipsychotics; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• the difference of Ki(cer) of [18 fluorine(F)]DOPA PET

  Subjects in the patient group will receive a intake of antipsychotics(amisulpride) for the six-week period and they will also undergo PET imaging at the baseline. After six-week marks, the investigators will determine treatment responders and nonresponders. And the investigators will detect the correlation between the capacity of presynaptic dopamine, treatment response and nonresponse in the patients.

  the difference of Ki(cer) between healthy controls and patient group at the baseline

Secondary Outcomes (3)

• clinical scale(Positive and Negative Syndrome Scale)

  change from baseline Positive and Negative Syndrome Scale and at 6 wk

• Age

  at baseline

• Sex

  at baseline

Study Arms (2)

patient group

EXPERIMENTAL

* 50 Drug-naïve patients with first episode psychosis (We anticipate the non-responder rate will be 30% of the patients) 1. Drug-naïve 2. Diagnosed as first episode psychosis 3. The total score of PANSS\>70 4. No co-morbid psychiatric illness (including drug dependence/abuse) * They will also undergo PET scan at the baseline. And the investigators are going to determine treatment response after 6 weeks of treatment with amisulpride. Also they should complete clinical scales at 0, 2, 4, 6, and 8 week.

Device: PET scan; Behavioral: clinical scale; Drug: 6 weeks of treatment with amisulpride

healthy control group

OTHER

* 12 healthy volunteers 1. No history of psychiatric disorder (including drug dependence/abuse) 2. No history of physical illness 3. No contra-indication to scanning * They will also undergo PET scan at the baseline

Device: PET scan

Interventions

PET scan DEVICE

The patient group and the healthy control group will undergo PET scan at the baseline. the investigators are going to measure striatal dopamine synthesis capacity using \[18 fluorine(F)\]DOPA positron emission tomography in drug-naïve first episode psychosis and determine treatment response after 6 weeks of treatment with amisulpride. Response will be defined as a \>30% reduction in symptom ratings on the Positive and Negative Syndrome Scale.

healthy control group; patient group

clinical scale BEHAVIORAL

Patient group should complete clinical scales at baseline and 6 week.

patient group

6 weeks of treatment with amisulpride DRUG

The investigators are going to measure striatal dopamine synthesis capacity using \[18 fluorine(F)\]DOPA positron emission tomography in drug-naïve first episode psychosis and determine treatment response after 6 weeks of treatment with amisulpride. Response will be defined as a \>30% reduction in symptom ratings on the Positive and Negative Syndrome Scale.

Also known as: amisulpride

patient group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient group (1) Patients who met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder (2) Patients diagnosed with first episode psychosis which occurred within 2 years and not having been treated with antipsychotics(Drug-naïve) (3) The total score of PANSS\>70
• Healthy control group (1) 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 (2) No history of physical illness (3) No contra-indication to scanning

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Positron-Emission Tomography; Mental Status and Dementia Tests; Therapeutics; Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Euitae Kim, Ph. D.

  Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 26, 2016
• Study Start: November 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

KR (2)