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Dose-finding Study With Lu AA24530 in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00599911
First received: December 28, 2007
Last updated: November 7, 2016
Last verified: November 2016
  Purpose
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

Condition Intervention Phase
Major Depressive Disorder
Drug: Lu AA24530
Drug: Duloxetine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Response rate, remission rate, and safety [ Time Frame: 6 weeks ]

Enrollment: 652
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA24530: 5 mg Drug: Lu AA24530
per oral, once daily for 6 weeks
Experimental: Lu AA24530: 10 mg Drug: Lu AA24530
per oral, once daily for 6 weeks
Experimental: Lu AA24530: 20 mg Drug: Lu AA24530
per oral, once daily for 6 weeks
Active Comparator: Duloxetine: 60 mg Drug: Duloxetine
per oral, once daily for 6 weeks
Placebo Comparator: Placebo Drug: Placebo
per oral, once daily for 6 weeks

Detailed Description:
According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599911

  Show 72 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Study Data/Documents: EMA EudraCT Results  This link exits the ClinicalTrials.gov site
Identifier: 2007-001071-11

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00599911     History of Changes
Other Study ID Numbers: 11918A
2007-001071-11 ( EudraCT Number )
Study First Received: December 28, 2007
Last Updated: November 7, 2016

Keywords provided by H. Lundbeck A/S:
Drug therapy
Depressive disorder
Antidepressive agents
Depressive symptoms
Affective disorders
Randomized controlled trial
Placebo-controlled
Double-blind
Active reference
Multicenter study

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2017