The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram - Full Text View

Sponsor:	Vanderbilt University
Collaborator:	Pfizer
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179257

Purpose

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	Intervention	Phase
Major Depressive Disorder	Drug: sertraline (Zoloft)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Sertraline hydrochloride Sertraline Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

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:

Hamilton Anxiety Scale Total score
Clinical Global Impressions - Severity Scale

Estimated Enrollment:	20
Study Start Date:	June 2004
Estimated Study Completion Date:	March 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179257

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University

Pfizer

Investigators

Principal Investigator:

Richard C Shelton, MD

Vanderbilt University

More Information

No publications provided

Study ID Numbers:	Lexapro Failure Study
Study First Received:	September 13, 2005
Last Updated:	September 8, 2006
ClinicalTrials.gov Identifier:	NCT00179257 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Failure to Escitalopram

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010