NCT Number: NCT00179257
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Treatment and study plan
Primary outcomes
-
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
-
Hamilton Anxiety Scale Total score
-
Clinical Global Impressions - Severity Scale
Sponsors and collaborators
Lead sponsor
Vanderbilt University
Other
Collaborators
- Pfizer
Registry information
Official study title
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
Important dates
- Study start
- 2004
- Study completion
- 2005
- First posted
- Sep 15, 2005
- Registry last updated
- Jun 2, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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