The Study of Atypical Antipsychotics-induced Metabolic Disturbances
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The Study of Atypical Antipsychotics-induced Metabolic Disturbances |
- glucose homeostasis [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- 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 |
psychiatric outpatient clinic and inpatient units
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| Taiwan | |
| Taipei Medical University-Municipal Wan-Fang Hospital | |
| Taipei, Taiwan, 116 | |
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 Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 17, 2013