A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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