Dose-finding Study With Lu AA24530 in Major Depressive Disorder

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Major Depressive Episode that has lasted at least 3 months

• Moderate to severe depression

Exclusion Criteria:

• Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and as assessed with the Mini-International Neuropsychiatric Interview (MINI)

• Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR

• Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration

• Electroconvulsive therapy within 6 months prior to Baseline

• Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study

• Clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance

• The patient is pregnant or breast-feeding