Clinical trial NCT00956189: Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome
Official title: Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Antipsychotic Agents
Metabolic Syndrome X
Identification
Prediction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Yu-Li Veterans Hospital
name: Yu-Li Hospital
First posted: 2009-08-11
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Metabolic profile
timeFrame: half/one year
Secondary outcomes:
measure: Clinical efficacy
timeFrame: half/one year
Other outcomes:
Locations:
city: Yu-Li
country: Taiwan
facility: Yu-Li Hospital
state: Hualien County
city: Yu-Li
country: Taiwan
facility: Yu-Li Veterans Hospital
state: Hualien County
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chao-Cheng Lin, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: