Major DepressionNCT00711737
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
An observational study of Major Depression and Generalized Anxiety Disorder, run by Changi General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Major Depression, Generalized Anxiety Disorder, Panic Disorder
- How many people
- 27 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2008to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients in psychiatric clinic in a general hosptial
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- metabolic parameters, escitalopram, metabolic syndrome, antidepressant
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder, Panic Disorder, Metabolic Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lai H Peh, MBBS, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711737
- Sponsor's protocol ID
- 2008.06
- Status last verified
- Jun 2011
- First submitted
- 8 Jul 2008
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
- ClinicalTrials.gov ID
- NCT00711737
- Acronym / sponsor ID
- 2008.06
- Keywords
- metabolic parameters, escitalopram, metabolic syndrome, antidepressant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients in psychiatric clinic in a general hosptial
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lai H Peh, MBBS principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression and Generalized Anxiety Disorder, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.