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The Study of Atypical Antipsychotics-induced Metabolic Disturbances

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ClinicalTrials.gov Identifier: NCT00937755
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : July 13, 2009
Sponsor:
Collaborators:
National Science Council, Taipei, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
Taipei Medical University Hospital

Brief Summary:

Schizophrenia is one of the most severe mental illnesses. The antipsychotic drugs, introduced in early 1950s, have revolutionized the treatment of schizophrenia. About 2 to 4 times as many patients relapse when treated with a placebo as do those treated with antipsychotic drugs. For these medications to be maximally beneficial, they must have an acceptable side effect profile and be taken as prescribed. One untoward effect of many antipsychotic drugs is weight gain. The extent of weight gain apparently varies by drug, which may be because of drugs'differing degrees of action on serotonergic, dopaminergic, histaminergic, and other neurotransmitter systems. Obesity is a threat to health and longevity. Weight gain may also cause patients taking antipsychotic medication to discontinue their medication, which may predispose them to relapse.

The pattern of weight gain and metabolic disturbance may vary between the different antipsychotic agents. The underlying mechanism and treatment of these adverse metabolic effects remain unclear. This study will recruit 60 schizophrenic patients during. The patients received monotherapy with atypical antipsychotics (olanzapine, quetiapine, or risperidone). The assessment of metabolic profile will be monitored at baseline, week 2, week 4, and week 8. The measurements include anthropometrical parameters, body composition, glucose level, insulin level, lipid profile, and leptin level. Intra-venous glucose tolerance test will be used to assess the insulin secretion and insulin sensitivity.

This proposal broadly aims to discover the underlying mechanism of antipsychotics induced metabolic disturbance and develop efficient treatment to correct it.


Condition or disease Phase
Schizophrenia Antipsychotics Phase 4

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Study of Atypical Antipsychotics-induced Metabolic Disturbances
Study Start Date : March 2006
Primary Completion Date : March 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Group/Cohort
olanzapine
olanzapine 10-20 mg/day
quetiapine
quetiapine 300-600 mg/day
risperidone
risperidone monotherapy, 2-4 mg/day



Primary Outcome Measures :
  1. glucose homeostasis [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. lipid homeostasis [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
psychiatric outpatient clinic and inpatient units
Criteria

Inclusion Criteria:

  • clinical diagnosis of schizophrenia
  • age 18-60 years

Exclusion Criteria:

  • received any SGAs prior to this study
  • medical conditions that may confound glucoregulatory assessment
  • pregnancy

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): NCT00937755


Locations
Taiwan
Taipei Medical University-Municipal Wan-Fang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University Hospital
National Science Council, Taipei, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)

ClinicalTrials.gov Identifier: NCT00937755     History of Changes
Other Study ID Numbers: F941101
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: July 13, 2009
Last Verified: July 2009

Keywords provided by Taipei Medical University Hospital:
schizophrenia
antipsychotics
glucose homeostasis
metabolic disturbance

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs