The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
NCT00179257
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram | |||
| Official Title ICMJE | The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to | |||
| Brief 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. | |||
| 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Major Depressive Disorder | |||
| Intervention ICMJE | Drug: sertraline (Zoloft) | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 20 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | March 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | United States | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00179257 | |||
| Other Study ID Numbers ICMJE | Lexapro Failure Study | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Richard C. Shelton, Vanderbilt University | |||
| Study Sponsor ICMJE | Vanderbilt University | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Vanderbilt University | |||
| Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||