The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: sertraline (Zoloft)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sertraline (Zoloft)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Scale Total score |  |  | 
| Clinical Global Impressions - Severity Scale |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Failure to Escitalopram