Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Drug: amisulpride; Drug: aripiprazole

• Registration Number: NCT00956189
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2009-11
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amisulpride	amisulpride	A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.
Aripiprazole	aripiprazole	A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole.

Primary Outcome Measures

Name	Time	Method
Metabolic profile	half/one year

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy	half/one year

Trial Locations

Locations (3)

Yu-Li Hospital; 🇨🇳 Yu-Li, Hualien County, Taiwan

Yu-Li Veterans Hospital; 🇨🇳 Yu-Li, Hualien County, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan