Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration 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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Drug: amisulpride; Drug: aripiprazole

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Hualien County
    • Yu-Li, Hualien County, Taiwan, 981
      • Yu-Li Hospital
    • Yu-Li, Hualien County, Taiwan, 981
      • Yu-Li Veterans Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolic profile	half/one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical efficacy	half/one year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Yu-Li Hospital; Yu-Li Veterans Hospital
• Investigators: Principal Investigator: Chao-Cheng Lin, M.D.,Ph.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: August 10, 2009
• First Submitted That Met QC Criteria: August 10, 2009
• First Posted (Estimate): August 11, 2009

Study Record Updates

• Last Update Posted (Estimate): January 3, 2013
• Last Update Submitted That Met QC Criteria: January 2, 2013
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Antipsychotic Agents; Prediction; Metabolic Syndrome X; Identification
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Angina Pectoris; Syndrome; Metabolic Syndrome; Microvascular Angina; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Aripiprazole; Amisulpride
• Other Study ID Numbers: 200812110M