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Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
amisulpride
aripiprazole
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Antipsychotic Agents, Metabolic Syndrome X, Identification, Prediction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Stage I for identification of metabolic syndrome:

Inclusion Criteria:

  • A diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, mood disorders, or anxiety disorders based on DSM-IV-TR criteria.
  • Age at least 20 years old.
  • The current antipsychotic drugs have been used for at least 3 months before evaluation.
  • Psychiatrically stable with Clinical Global Impression of Severity scale (CGI-S) not greater than 5

Exclusion Criteria:

  • Severe uncontrolled medical illnesses, including cardiovascular, hepatic, renal and metabolic diseases (eg. cancer, poor-control hypertension, diabetes mellitus, and other metabolic diseases).
  • Organic mental or neurological disorder, substance abuse or dependence (alcohol, amphetamine, heroin).
  • Pregnant or breast-feeding women.
  • Patients from Yuli Veterans Hospital, who attended our previous study of identification model.

Stage II for switch response:

Inclusion Criteria:

  • The same as Stage I criteria.
  • Fulfill the metabolic syndrome criteria.

Exclusion Criteria:

  • The same as Stage I criteria except the 4th item.
  • Treated with depot form of antipsychotics.

Sites / Locations

  • Yu-Li Hospital
  • Yu-Li Veterans Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Amisulpride

Aripiprazole

Arm Description

A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.

A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole.

Outcomes

Primary Outcome Measures

Metabolic profile

Secondary Outcome Measures

Clinical efficacy

Full Information

First Posted
August 10, 2009
Last Updated
January 2, 2013
Sponsor
National Taiwan University Hospital
Collaborators
Yu-Li Veterans Hospital, Yu-Li Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00956189
Brief Title
Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome
Official Title
Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Yu-Li Veterans Hospital, Yu-Li Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators developed an easy identification model to identify metabolic syndrome in patients with schizophrenia or schizoaffective disorder who received treatment of clozapine, olanzapine, or risperidone. The accuracy of the investigators' models showed well. In the study, the investigators aim to (1) to examine whether the developed identification models can be generalized to patients taking other antipsychotics or patients with other diagnoses; (2) to develop an easy risk score and validate it; (3) to switch antipsychotics to amisulpride or aripiprazole for those with metabolic syndrome, and compare the changes of metabolic parameters including adiponectin, and analyze their association with genetic variants, demography, and clinical variables; (4) to establish models using artificial neural network and statistic method to predict metabolic response after a switch to amisulpride or aripiprazole; (5) to investigate the effect of antipsychotics on adiponectin gene expression and secretion during the differentiation process of 3T3L1 adipocytes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Antipsychotic Agents, Metabolic Syndrome X, Identification, Prediction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amisulpride
Arm Type
Experimental
Arm Description
A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.
Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole.
Intervention Type
Drug
Intervention Name(s)
amisulpride
Other Intervention Name(s)
Solian
Intervention Description
Amisulpride dosage was increased from 200 up to a maximum of 1000 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition.
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Aripiprazole dosage was increased from 5-7.5 up to a maximum of 30 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition.
Primary Outcome Measure Information:
Title
Metabolic profile
Time Frame
half/one year
Secondary Outcome Measure Information:
Title
Clinical efficacy
Time Frame
half/one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Stage I for identification of metabolic syndrome: Inclusion Criteria: A diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, mood disorders, or anxiety disorders based on DSM-IV-TR criteria. Age at least 20 years old. The current antipsychotic drugs have been used for at least 3 months before evaluation. Psychiatrically stable with Clinical Global Impression of Severity scale (CGI-S) not greater than 5 Exclusion Criteria: Severe uncontrolled medical illnesses, including cardiovascular, hepatic, renal and metabolic diseases (eg. cancer, poor-control hypertension, diabetes mellitus, and other metabolic diseases). Organic mental or neurological disorder, substance abuse or dependence (alcohol, amphetamine, heroin). Pregnant or breast-feeding women. Patients from Yuli Veterans Hospital, who attended our previous study of identification model. Stage II for switch response: Inclusion Criteria: The same as Stage I criteria. Fulfill the metabolic syndrome criteria. Exclusion Criteria: The same as Stage I criteria except the 4th item. Treated with depot form of antipsychotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao-Cheng Lin, M.D.,Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yu-Li Hospital
City
Yu-Li
State/Province
Hualien County
ZIP/Postal Code
981
Country
Taiwan
Facility Name
Yu-Li Veterans Hospital
City
Yu-Li
State/Province
Hualien County
ZIP/Postal Code
981
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

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Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

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