The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Major Depressive Disorder
Drug: sertraline (Zoloft)
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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