Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborators:
Yu-Li Veterans Hospital
Yu-Li Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00956189
First received: August 10, 2009
Last updated: January 2, 2013
Last verified: November 2012
  Purpose

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 Intervention
Metabolic Syndrome X
Drug: amisulpride
Drug: aripiprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Metabolic profile [ Time Frame: half/one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical efficacy [ Time Frame: half/one year ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: November 2009
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956189

Locations
Taiwan
Yu-Li Veterans Hospital
Yu-Li, Hualien County, Taiwan, 981
Yu-Li 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
Investigators
Principal Investigator: Chao-Cheng Lin, M.D.,Ph.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00956189     History of Changes
Other Study ID Numbers: 200812110M
Study First Received: August 10, 2009
Last Updated: January 2, 2013
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Sultopride
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014