Noradrenergic Augmentation of SSRI Therapy in Patients With Depression Unresponsive or Incompletely Responsive to SSRI Monotherapy

Eli Lilly and Company1 site in 1 country214 target enrollmentJune 2003

ConditionsDepressive Symptoms

DrugsAtomoxetine Hydrochloride Sertraline Placebo

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Depressive Symptoms
Sponsor: Eli Lilly and Company
Enrollment: 214
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

January 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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