Efficacy and Safety of Lu AA21004 in Acute Treatment of Major Depressive Disorder - Full Text View

Purpose

The purpose of the study is to evaluate the efficacy and the safety of two fixed doses of Lu AA21004 in the treatment of Major Depressive Disorder.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA21004 Drug: Duloxetine Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

To evaluate the efficacy of two fixed doses of Lu AA21004 (15 or 20 mg/day) versus placebo as assessed by the change from baseline in MADRS total score after 8 weeks of treatment in adult patients with moderate to severe MDD. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the effect of Lu AA21004 to that of placebo at Week 8 on patients who respond (response defined as a >=50% decrease in the MADRS total score from baseline) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To compare the effect of Lu AA21004 to that of placebo at Week 8 on global improvement as assessed by CGI-I [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To compare the effect of Lu AA21004 to that of placebo at Week 8 on depressive symptoms in patients with a high baseline level of anxiety (defined by HAM-A), as assessed by MADRS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To compare the effect of Lu AA21004 to that of placebo at Week 8 on patients who are in remission (remission defined as a MADRS total score <=10) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To compare the effect of Lu AA21004 to that of placebo at Week 8 on disability as assessed by SDS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of Lu AA21004 on sexual function as assessed by ASEX versus placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of Lu AA21004 (15 or 20 mg/day) versus placebo during treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
To evaluate the potential discontinuation symptoms after abrupt discontinuation of treatment with Lu AA21004 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	607
Study Start Date:	May 2010
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lu AA21004: 15 mg	Drug: Lu AA21004 per oral; 15 mg/day Other Name: Vortioxetine
Experimental: Lu AA21004: 20 mg	Drug: Lu AA21004 per oral; 20 mg/day Other Name: Vortioxetine
Active Comparator: Duloxetine: 60 mg	Drug: Duloxetine 60 mg/day
Placebo Comparator: Placebo	Drug: Placebo Daily

Detailed Description:

Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA21004 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient has recurrent Major Depressive Disorder as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
The patient has a MADRS total score >=26
The patient has a CGI-S score >=4

Exclusion Criteria:

Any current anxiety psychiatric disorder as defined in the DSM-IV TR
Current diagnosis or 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
Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
Use of any psychoactive medication 2 weeks prior to screening and during the study
The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140906

Show 45 Study Locations

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided

Responsible Party:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT01140906 History of Changes
Other Study ID Numbers:	13267A, 2009-017523-26
Study First Received:	June 9, 2010
Last Updated:	June 18, 2012
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Sweden: Medical Products Agency Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by H. Lundbeck A/S:

Major depressive disorder
Placebo-controlled
Active reference

Multicenter study
Randomised study
Acute treatment

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013