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NCT Number: NCT00956189

Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yu-Li Hospital, Yuli, Hualien County, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amisulpride

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.

Other names: Solian

Aripiprazole

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.

Other names: Abilify

Primary outcomes

  1. Metabolic profile

    Time frame: half/one year

Secondary outcomes

  1. Clinical efficacy

    Time frame: half/one year

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Yu-Li Hospital
  • Yu-Li Veterans Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2009
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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