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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179257
• Other study ID #: Lexapro Failure Study
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 1, 2015
• Start date: June 2004
• Est. completion date: March 2005

Study information

• Verified date: June 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• sertraline (Zoloft)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
Primary	Hamilton Rating Scale for Depression (21-item) total score
Primary	Clinical Global Impressions - Improvement Scale
Secondary	Hamilton Anxiety Scale Total score
Secondary	Clinical Global Impressions - Severity Scale