Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956189
• Other study ID #: 200812110M
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: January 2, 2013
• Start date: November 2009
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Yu-Li Hospital	Yu-Li	Hualien County
Taiwan	Yu-Li Veterans Hospital	Yu-Li	Hualien County

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Yu-Li Hospital, Yu-Li Veterans Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic profile		half/one year	Yes
Secondary	Clinical efficacy		half/one year	No