A Study of Patients With Major Depressive Disorder and Residual Apathy

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Citalopram; Dexetimide; Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder

• Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control

• Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score >30 at screening and randomization.

• Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent sadness) score of <2 at screening and randomization.

• Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.

Exclusion Criteria:

• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device

• Have previously completed or withdrawn from this study or any other study investigating duloxetine.

• Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time.

• Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk

• Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months

• Presence of an Axis II disorder

• Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study

• Positive urine drug screen for any substance of abuse or excluded medication.

• Are pregnant or breast-feeding.

• Serious medical illness, requires hospitalization during the study

• Have uncontrolled narrow-angle glaucoma.

• Have acute liver injury or severe cirrhosis

• Abnormal thyroid stimulating hormone (TSH) concentration

• Amphetamines, dopaminergic medications or modafinil within 14 days prior to randomization or potential need to use such medications during the study or within 14 days of discontinuation of study drug.