Early Prediction of Clinical Response in Patients With Sc... | NCT02075528

Studies
Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER

NCT02075528

Sponsor

Taipei City Hospital

Status

Completed

Last Update Posted

Mar 3, 2014Estimated

Enrollment

41Actual

Phase

Phase 4

Conditions

Schizophrenia
Schizoaffective Disorder

Interventions

Paliperidone ER

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

May 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Feb 25, 2014

First Submission Date that Met QC Criteria

Feb 27, 2014

First Posted Date

Mar 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2014

Last Update Posted Date

Mar 3, 2014Estimated

Name	Class
Johnson & Johnson Taiwan Ltd	INDUSTRY
Taipei Institute of Pathology	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable.

The primary aim of this study is to investigate:

. whether the early prediction model used in other atypicals could also be applied in paliperidone ER.
. The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study

Detailed Description

Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paliperidone Extended Release (ER)	Experimental	The participants were assigned to receive a fixed dosage of 9 mg/d of paliperidone ER for the first 2 weeks. The paliperidone ER dosage was adjusted flexibly after 2 weeks according to the clinical judgment of the physicians in charge.	Drug: Paliperidone ER

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paliperidone ER	Drug	9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically	Paliperidone Extended Release (ER)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)		Baseline (day 0) and Day 42

Secondary Outcomes

Measure	Description	Time Frame
Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)		Day 0 and 42

Other Outcomes

Measure	Description	Time Frame
pharmacokinetic (levels of 9-OH risperidone)		day 14 and day 42

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
a minimal baseline total score of 60 on the PANSS
those who had not received long-acting antipsychotic injection for the preceding 6 months
physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.

Exclusion Criteria:

diagnosis of substance (including alcohol) dependence in the previous 6 months
a medical condition that could affect absorption, metabolism, or excretion of the study drug
substantial risk of suicide or violent behavior
pregnancy or breastfeeding
documented organic disease of the central nervous system
unstable or critical untreated medical illness
history of clozapine treatment in the previous 3 months
participation in an investigational drug trial in the 30 days before screening.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MING-CHYI HUANG, M.D., Ph.D.	Department of Psychiatry, Taipei City Hospital, Songde Branch, Taipei, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei City Hospital, Songde Branch		Taipei		110	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068882	Paliperidone Palmitate

Ancestor Terms

ID	Term
D007555	Isoxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided