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Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00956189
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Metabolic Syndrome X Drug: amisulpride Drug: aripiprazole

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome
Study Start Date : November 2009
Primary Completion Date : August 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Amisulpride
A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.
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.
Other Name: Solian
Experimental: Aripiprazole
A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole.
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.
Other Name: Abilify

Outcome Measures

Primary Outcome Measures :
  1. Metabolic profile [ Time Frame: half/one year ]

Secondary Outcome Measures :
  1. Clinical efficacy [ Time Frame: half/one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956189

Yu-Li Hospital
Yu-Li, Hualien County, Taiwan, 981
Yu-Li Veterans Hospital
Yu-Li, Hualien County, Taiwan, 981
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Yu-Li Veterans Hospital
Yu-Li Hospital
Principal Investigator: Chao-Cheng Lin, M.D.,Ph.D. National Taiwan University Hospital
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00956189     History of Changes
Other Study ID Numbers: 200812110M
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
Antipsychotic Agents
Metabolic Syndrome X

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents