Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months

This study has been completed.
Sponsor:
Information provided by:
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT00711737
First received: July 8, 2008
Last updated: June 15, 2011
Last verified: June 2011

July 8, 2008
June 15, 2011
September 2008
October 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00711737 on ClinicalTrials.gov Archive Site
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Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
Open-label Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months

The purpose of this study is to explore the changes in metabolic parameters in patients treated with escitalopram for six months for major depression, generalized anxiety disorder or panic disorder, with or without agoraphobia.

This is an open-label study, with 4 scheduled visits. Recruitment of 100 subjects. Assessments include demographics, diagnosis, smoking frequency, Clinical Global Scale (CGI-S), weight, height,blood pressure, waist and hip circumference and fasting blood glucose and lipd profile.

Statistical analysis will be exploratory and mainly descriptive.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Outpatients in psychiatric clinic in a general hosptial

  • Major Depression
  • Generalized Anxiety Disorder
  • Panic Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Give informed consent
  • Requires pharmacological treatment with escitalopram for major depression, generalized anxiety disorder or panic disorder
  • Aged 21 years old and above
  • Able to comprehend and comply with protocol
  • Not pregnant and if of child-bearing age, using adequate methods of contraception

Exclusion Criteria:

  • Currently taking or has taken in previous 3 months, any other antidepressants, antipsychotics, mood stabilizers, weight loss or lipid-profile modifying drugs
  • Contraindications to escitalopram
  • Unstable medical illness and/or is already under treatment of diabetes, hypertension, dyslipidemia, ischemic heart disease
  • History of non-response to escitalopram
  • Meets IDF definition of metabolic syndrome
  • Significant risk of suicide
  • Primary diagnosis or comorbid diagnosis of psychotic disorder, bipolar disorder, substance dependence and/or dementia
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00711737
2008.06
No
Changi General Hospital
Changi General Hospital
Not Provided
Principal Investigator: Lai H Peh, MBBS Changi General Hospital
Changi General Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP