The Study of Atypical Antipsychotics-induced Metabolic Disturbances

This study has been completed.
Sponsor:
Collaborators:
National Science Council, Taipei, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00937755
First received: July 10, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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 Phase
Schizophrenia
Antipsychotics
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Study of Atypical Antipsychotics-induced Metabolic Disturbances

Resource links provided by NLM:


Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • glucose homeostasis [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • lipid homeostasis [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: March 2006
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
olanzapine
olanzapine 10-20 mg/day
quetiapine
quetiapine 300-600 mg/day
risperidone
risperidone monotherapy, 2-4 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00937755     History of Changes
Other Study ID Numbers: F941101
Study First Received: July 10, 2009
Last Updated: July 10, 2009
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014