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Antipsychotics and Metabolic Syndrome

This study has suspended participant recruitment.
(this study has not finding place)
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00636753
First received: March 7, 2008
Last updated: July 29, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life.


Condition
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Biospecimen Retention:   None Retained

whole blood, serum/plasma


Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
schizophrenic patients
2
controls

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with debut of schizophrenia, controls from database

Criteria

Inclusion Criteria:

  • Gender male
  • Age 18-45
  • Debut drug-naive schizophrenics,
  • Caucasians
  • Consent given to take part in the project

Exclusion Criteria:

  • Compliance-problems
  • Major lung-/kidney/hart/lever disorders
  • Abuse of alcohol/drugs
  • Diabetes 1 and 2
  • Antihypertensive
  • Anticholesterol-reducing medication
  • Patients under duress
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636753

Locations
Denmark
Psychiatric Center Glostrup
Copenhagen, Nordre Ringvej 28-69, Glostrup, Denmark, 2600
Psychiatric Center Glostrup
Nordre Ringvej 28-69, Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
  More Information

No publications provided

Responsible Party: dr.med., centerchef Henrik Lublin, Psychiatric Center Glostrup
ClinicalTrials.gov Identifier: NCT00636753     History of Changes
Other Study ID Numbers: HC-2007-0070
Study First Received: March 7, 2008
Last Updated: July 29, 2010
Health Authority: Denmark : Drug Administration
Denmark : Ethic Commitee
Denmark :Good Clinical Practice-administration

Keywords provided by Glostrup University Hospital, Copenhagen:
Metabolic and endocrine changes in schizophrenic patients by antipsychotics treatment.

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
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 May 22, 2013