Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956189

Enrollment

132

Registered

2009-08-11

Start date

2009-11-30

Completion date

2012-10-31

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X

Keywords

Antipsychotic Agents, Metabolic Syndrome X, Identification, Prediction

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.

Interventions

DRUGamisulpride

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.

DRUGaripiprazole

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Metabolic profile	half/one year

Secondary

Measure	Time frame
Clinical efficacy	half/one year

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026