A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

Lilly

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: Duloxetine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422162

F1J-BI-HMES (Other Identifier)

10614 (Registry Identifier)

Details and patient eligibility

About

An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.

Enrollment: 339 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Male or female patients of ≥ 18 years of age that meet criteria for severe Major Depressive Disorder, without psychotic features (according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, [DSM-IV] and confirmed by Mini International Neuropsychiatric Interview [MINI]).

• With a total score Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 30 and 6-item Hamilton Depression Rating Scale (HAMD-6) ≥ 12 and Clinical Global Impression of Severity (CGI-Severity) ≥ 4 at both screening and baseline.
• Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4.
• Patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
• Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure.

Exclusion criteria

• More than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration of two different antidepressant therapies.
• Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode.
• Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment.
• Any previous diagnosis of a bipolar disorder, schizophrenia or OCD.
• Depression with catatonic features (according to DSM-IV), depression with post-partum onset, or organic mental disorders.
• The presence of an Axis II disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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339 participants in 2 patient groups

Duloxetine Hydrochloride (60 mg)

Experimental group

Description:

Up to Week 4: 60 milligrams (mg) every morning and placebo every evening, by mouth (PO). Week 4 to Week 8: Responders continued on same dose as before; Nonresponders received 60 mg every morning and 60 mg every evening added to the placebo

Treatment:

Drug: Duloxetine hydrochloride

Drug: Placebo

Duloxetine Hydrochloride (120 mg)

Experimental group

Description:

Up to Week 4: 60 mg every morning and 60 mg every evening, PO. Week 4 to Week 8: Responders continued on same dose as before; Nonresponders continued as before with a placebo capsule added to the evening dose

Treatment:

Drug: Duloxetine hydrochloride

Drug: Placebo