- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00711737
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
June 15, 2011 updated by: Changi General Hospital
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.
Study Overview
Status
Completed
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 529889
- Changi General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatients in psychiatric clinic in a general hosptial
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lai H Peh, MBBS, Changi General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
July 8, 2008
First Submitted That Met QC Criteria
July 8, 2008
First Posted (Estimate)
July 9, 2008
Study Record Updates
Last Update Posted (Estimate)
June 17, 2011
Last Update Submitted That Met QC Criteria
June 15, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008.06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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