Major Depressive DisorderPhase 3NCT00179257
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
A Phase 3 study testing sertraline (Zoloft) in people with Major Depressive Disorder, run by Vanderbilt University.
Trial summary
The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in patients with major depressive disorder (MDD) who have shown inadequate response ot escitalopram. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- sertraline (Zoloft)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Mar 2005
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses
- Ham-D 21 item score of greater than or equal to 18
- Age 18 and above
- Ability and willingness to provide consent for participation
- Failure to respond to escitalopram
Who cannot join
- Diagnosis of Bipolar Disorder or any psychotic disorder
- Alcohol or drug abuse or dependence currently or in the last 6 months
- A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
- Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
- Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
- Use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of PRN use of diazepam 10 mg/day or its equivalent
Show all 9Show fewer
- Presence of serious and/or unstable medical condition
- Score of 3 or 4 on the suicide item (item 3) of the Ham-D scale
- Known sensitivity of sertraline
About this study
Official title: The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in patients with major depressive disorder (MDD) who have shown inadequate response ot escitalopram.
Read the detailed description
Eight week open-label flexible dose trial in adult outpatients diagnosed with Major Depressive Disorder (MDD) who have had a prior failure with escitalopram. Failure is operationally defined as either premature discontinuation because of side effects or the report of an incomplete response to escitalopram, minimum dose 10mg/day, maintain for 3 weeks or more. 10mg/day was chosen because 1) it is the most commonly prescribed single dose of escitalopram in clinical practice, 2) it is equivalent to approx. 30mg/day of arcemic citalopram and 3) escitalopram has very high potency at the serotonin transporter (Ki=1.1); this means that escitalopram would be expected to saturate the transporter at relatively low doses. A total of twenty patients will be treated.
- Conditions
- Major Depressive Disorder
- Being tested
- sertraline (Zoloft)
- Keywords
- Failure to Escitalopram
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertraline (Zoloft)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
Hamilton Rating Scale for Depression (21-item) total score
Clinical Global Impressions - Improvement Scale
Secondary outcomes (2)
Hamilton Anxiety Scale Total score
Clinical Global Impressions - Severity Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Richard C. Shelton, Vanderbilt University
- Investigators
- Richard C Shelton, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179257
- Sponsor's protocol ID
- Lexapro Failure Study
- Status last verified
- Jun 2015
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
- ClinicalTrials.gov ID
- NCT00179257
- Acronym / sponsor ID
- Lexapro Failure Study
- Conditions
- Major Depressive Disorder
- Keywords
- Failure to Escitalopram
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2004
- Study completion
- Mar 2005
- First posted
- 15 Sep 2005 (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 is to determine the efficacy, safety, and tolerability of sertraline in patients with major depressive disorder (MDD) who have shown inadequate response ot escitalopram.
Detailed description
Eight week open-label flexible dose trial in adult outpatients diagnosed with Major Depressive Disorder (MDD) who have had a prior failure with escitalopram. Failure is operationally defined as either premature discontinuation because of side effects or the report of an incomplete response to escitalopram, minimum dose 10mg/day, maintain for 3 weeks or more. 10mg/day was chosen because 1) it is the most commonly prescribed single dose of escitalopram in clinical practice, 2) it is equivalent to approx. 30mg/day of arcemic citalopram and 3) escitalopram has very high potency at the serotonin transporter (Ki=1.1); this means that escitalopram would be expected to saturate the transporter at relatively low doses. A total of twenty patients will be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses
- Ham-D 21 item score of greater than or equal to 18
- Age 18 and above
- Ability and willingness to provide consent for participation
- Failure to respond to escitalopram
Key exclusion criteria (9 listed)
- Diagnosis of Bipolar Disorder or any psychotic disorder
- Alcohol or drug abuse or dependence currently or in the last 6 months
- A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
- Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
- Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertraline (Zoloft) | Drug | – |
Primary outcome
Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
Hamilton Rating Scale for Depression (21-item) total score
Clinical Global Impressions - Improvement Scale
2 secondary outcomes
Hamilton Anxiety Scale Total score
Clinical Global Impressions - Severity Scale
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 2 Jun 2015.
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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.
Richard C Shelton, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sertraline (Zoloft) in people with Major Depressive Disorder, run by Vanderbilt University.
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 9 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 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 2 Jun 2015.