Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

NCT ID: NCT00956189

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-10-31

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.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Amisulpride

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

Group Type: EXPERIMENTAL

amisulpride

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

aripiprazole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Solian; Abilify

Eligibility Criteria

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

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

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:

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yu-Li Veterans Hospital

OTHER_GOV

Sponsor Role: collaborator

Yu-Li Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao-Cheng Lin, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Yu-Li Hospital

Yuli, Hualien County, Taiwan

Yu-Li Veterans Hospital

Yuli, Hualien County, Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

200812110M

Identifier Type: -

Identifier Source: org_study_id