Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00956189

Collaborator

Yu-Li Veterans Hospital (Other), Yu-Li Hospital (Other)

132

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome X	Drug: amisulpride Drug: aripiprazole	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amisulpride A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.	Drug: amisulpride 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. Other Names: Solian
Experimental: Aripiprazole A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole.	Drug: aripiprazole 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. Other Names: Abilify

Arm

Intervention/Treatment

Experimental: Amisulpride

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

Drug: amisulpride

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.

Other Names:

Solian

Experimental: Aripiprazole

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

Drug: aripiprazole

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.

Other Names:

Abilify

Outcome Measures

Primary Outcome Measures

Metabolic profile [half/one year]

Secondary Outcome Measures

Clinical efficacy [half/one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.