Combination Therapy in Patients With Depression - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00485862

Purpose

The purpose of the study is to compare sertraline and atomoxetine/sertraline combination therapy in patients with persistent depressive symptoms.

Condition	Intervention	Phase
Depressive Symptoms	Drug: Atomoxetine Hydrochloride Drug: Sertraline Drug: Placebo	Phase IV

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Noradrenergic Augmentation of SSRI Therapy in Patients With Depression Unresponsive or Incompletely Responsive to SSRI Monotherapy

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Test the hypothesis that augmentation of sertraline with atomoxetine for approximately 8 weeks will results in a statistically significantly greater symptom reduction in depressed patients compared with continued therapy with sertraline alone

Secondary Outcome Measures:

To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in patients partially responsive or unresponsive to an adequate trial with sertraline monotherapy
To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in the subgroup of partial responders to an adequate trial with sertraline monotherapy
To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in the subgroup of nonresponders to an adequate trial with sertraline monotherapy
To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in the subgroup of patients with less than a 50% reduction in baseline symptom severity after an adequate trial with sertraline monotherapy
To compare the effects of the combination of sertraline plus atomoxetine with continued sertraline monotherapy on cognition in patients with no or partial response after an adequate trail with sertraline alone
To compare the efficacy of the combination of sertraline plus atomoxetine with continued sertraline monotherapy in patients with no or partial response after an adequate trial with sertraline alone as measured by remission rates
To test the hypotheses that patients homozygous or heterozygous for the short allele of serotonin transporter will be less responsive to sertraline than patients homozygous for the long allele
To test the hypotheses that patients homozygous or heterozygous for the short allele of the serotonin transporter who have no or partial response to sertraline therapy will respond when atomoxetine is added to the treatment regimen

Enrollment:	214
Study Start Date:	June 2003
Study Completion Date:	January 2005

Eligibility

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

Criteria

Inclusion Criteria:

Meet DSM-IV criteria for major depression with a HAMD-17 rating scale score of at least 18 at visit 1
Adult men or women, 18 years of age or older
Must be able to swallow capsules
Laboratory results must show no clinically significant abnormalities
If suicidal ideation is present, the investigator should assess its severity and the potential need for other interventions and determine whether these are compatible with study participation

Exclusion Criteria:

Have a documented history of Bipolar I or II disorder, or of psychosis.
Have a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control.
Have a history of ADHD
Have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions
Are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485862

Locations

United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seattle, Washington, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	6066, B4Z-MC-LYBN
Study First Received:	June 11, 2007
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00485862
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Depression
Atomoxetine
Sertraline

Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009