Combination Therapy in Patients With Depression

Lilly

Status and phase

Completed

Phase 4

Conditions

Depressive Symptoms

Treatments

Drug: Atomoxetine Hydrochloride

Drug: Sertraline

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

6066

B4Z-MC-LYBN

Details and patient eligibility

About

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

Enrollment

214 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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