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
  Purpose

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.


Condition
Major Depression
Generalized Anxiety Disorder
Panic Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Open-label Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months

Resource links provided by NLM:


Further study details as provided by Changi General Hospital:

Enrollment: 27
Study Start Date: September 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients in psychiatric clinic in a general hosptial

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711737

Locations
Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Lai H Peh, MBBS Changi General Hospital
  More Information

No publications provided

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT00711737     History of Changes
Other Study ID Numbers: 2008.06
Study First Received: July 8, 2008
Last Updated: June 15, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Changi General Hospital:
metabolic parameters
escitalopram
metabolic syndrome
antidepressant

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Panic Disorder
Depressive Disorder, Major
Mental Disorders
Behavioral Symptoms
Mood Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 28, 2014