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

Vanderbilt University

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: sertraline (Zoloft)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00179257

Lexapro Failure Study

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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