NCT00956189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 3, 2013

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

August 10, 2009

Last Update Submit

January 2, 2013

Conditions

Metabolic Syndrome X

Keywords

Antipsychotic AgentsMetabolic Syndrome XIdentificationPrediction

Outcome Measures

Primary Outcomes (1)

  • Metabolic profile

    half/one year

Secondary Outcomes (1)

  • Clinical efficacy

    half/one year

Study Arms (2)

Amisulpride

EXPERIMENTAL

A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.

Drug: amisulpride

Aripiprazole

EXPERIMENTAL

A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole.

Drug: aripiprazole

Interventions

amisulprideDRUG

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.

Also known as: Solian
Amisulpride
aripiprazoleDRUG

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.

Also known as: Abilify
Aripiprazole

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • The same as Stage I criteria.
  • Fulfill the metabolic syndrome criteria.
  • The same as Stage I criteria except the 4th item.
  • Treated with depot form of antipsychotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yu-Li Hospital

Yuli, Hualien County, 981, Taiwan

Location

Yu-Li Veterans Hospital

Yuli, Hualien County, 981, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

AmisulprideAripiprazole

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chao-Cheng Lin, M.D.,Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

January 3, 2013

Record last verified: 2012-11

Locations

TW(3)