A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

Lilly

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Duloxetine hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00536471

11669

F1J-US-HMFS

Details and patient eligibility

About

Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.

Enrollment: 776 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients
• Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
• Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2
• Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2
• Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion criteria

• Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
• Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia
• Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD
• Patients with uncontrolled narrow-angle glaucoma
• Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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776 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

duloxetine 60 milligrams (mg) every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months

Treatment:

Drug: Duloxetine hydrochloride

B

Placebo Comparator group

Description:

placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months

Treatment:

Drug: Placebo