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NCT00711737 Clinical Trial

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

Generalized Anxiety Disorder Clinical Trial

Official title:
Open-label Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00711737
Other study ID # 2008.06
Secondary ID
Status Completed
Phase N/A
First received July 8, 2008
Last updated June 15, 2011
Start date September 2008
Est. completion date October 2010

Study information
Verified date June 2011
Source Changi General Hospital
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Singapore Changi General Hospital Singapore

Sponsors (1)
Lead Sponsor Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

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