A Study of Lu AA21004 in Comparison to Agomelatine in Adults Suffering From Major Depression Who Did Not Respond Well to Previous Medication - Full Text View

Purpose

The objective of the present study is to evaluate whether Lu AA21004 (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA21004 Drug: agomelatine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

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

Primary Outcome Measures:

Efficacy of flexible doses of Lu AA21004 vs. flexible doses of agomelatine on depressive symptoms in patients with MDD who have responded inadequately to SRI antidepressant monotherapy as assessed by the change from baseline in MADRS total score [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
Major Depressive Disorder (MDD)

Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. Higher scores indicate greater severity of symptoms.

Secondary Outcome Measures:

Efficacy of flexible doses of Lu AA21004 vs. flexible doses of agomelatine over the 12 weeks of treatment on depressive symptoms as assessed by the change from baseline in MADRS total score [ Time Frame: Baseline and week 1, 2, 3, 4 and 12 ] [ Designated as safety issue: No ]
Safety and tolerability of flexible doses of Lu AA21004 vs. flexible doses of agomelatine over the 12 weeks of treatment as assessed by reported adverse events [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: Yes ]

Enrollment:	501
Study Start Date:	January 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lu AA21004	Drug: Lu AA21004 10 to 20 mg capsule orally per day Other Name: Vortioxetine
Active Comparator: agomelatine	Drug: agomelatine 25 to 50 mg capsule orally per day Other Name: Valdoxan

Eligibility

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

Criteria

Inclusion Criteria:

The patient is being treated with an SRI antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
MADRS total score ≥22 at the Screening Visit and Baseline
The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception

Exclusion Criteria:

The patient has any current Axis I disorders (DSM-IV criteria) other than MDD, General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
The patient is at significant risk of suicide
The patient is currently receiving formal psychotherapy or other psychoactive medications

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488071

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Locations

Austria
AT004
Neunkirchen, Austria, 2620
AT003
Vienna, Austria, 1010
Belgium
BE001
Brugge, Belgium, 8310
BE003
Sint-Niklaas, Belgium, 9100
Bulgaria
BG001
Bourgas, Bulgaria, 8000
BG002
Pazardzhik, Bulgaria, 4400
BG003
Sofia, Bulgaria
BG005
Sofia, Bulgaria, 1377
BG004
Varna, Bulgaria, 90110
Czech Republic
CZ003
Brno, Czech Republic, 602 00
CZ012
Brno, Czech Republic, 61500
CZ005
Olomouc, Czech Republic, 779 00
CZ004
Praha, Czech Republic, 158 00
CZ006
Praha, Czech Republic, 10000
CZ009
Praha 1, Czech Republic, 11000
CZ008
Praha 10, Czech Republic, 10000
CZ002
Praha 6, Czech Republic, 16000
CZ010
Praha 9, Czech Republic, 19000
Estonia
EE003
Parnu, Estonia, 80012
EE001
Tallinn, Estonia, 10617
EE005
Tallinn, Estonia, 11615
EE002
Tartu, Estonia, 50406
EE004
Tartu, Estonia, 50417
Germany
DE005
Berlin, Germany, 10245
DE004
Gelsenkirchen, Germany, 45879
DE003
Heidelberg, Germany, 69115
DE001
Leipzig, Germany, 04159
Italy
IT001
Milan, Italy, 20122
IT002
Turin, Italy, 10126
Lithuania
LT001
Kaunas, Lithuania, 50009
LT003
Kaunas, Lithuania, 50185
LT004
Klaipeda, Lithuania, 91251
LT006
Palanga, Lithuania, 00135
LT002
Vilnius, Lithuania, 10204
LT005
Vilnius, Lithuania, 09112
Poland
PL001
Gdansk, Poland, 80-542
PL002
Gdynia, Poland, 81-361
PL008
Gorlice, Poland, 38-300
PL006
Lublin, Poland, 20-045
PL007
Lublin, Poland, 20-109
PL003
Skorzewo, Poland, 60-185
PL005
Torun, Poland, 87-100
PL010
Tuszyn, Poland, 95-080
Romania
RO005
Arad, Romania, 310022
RO002
Bucharest, Romania, 041914
RO003
Bucharest, Romania, 041915
RO004
Bucharest, Romania, 041914
RO001
Craiova, Romania, 200260
RO007
Focsani, Romania, 620165
Russian Federation
RU001
Ekaterinburg, Russian Federation, 620030
RU008
Lipetsk, Russian Federation, 398007
RU002
Novosibirsk, Russian Federation, 630091
RU004
Saratov, Russian Federation, 410028
RU014
St Petersburg, Russian Federation, 192019
RU005
St. Petersburg, Russian Federation, 191119
RU006
St. Petersburg, Russian Federation, 190005
RU007
St. Petersburg, Russian Federation, 190013
RU012
St. Petersburg, Russian Federation, 190121
RU009
St.Petersburg, Russian Federation, 192019
RU003
Tomsk, Russian Federation, 634014
RU013
Tonnel'nyy, Russian Federation, 357034
Spain
ES003
Alcoy Alicante, Spain, 03804
ES006
Barcelona, Spain, 08003
ES005
Madrid, Spain, 28029
ES007
Madrid, Spain, 08029
ES002
Palma de Mallorca, Spain, 07010
ES004
Sabadell Barcelona, Spain, 08208
Sweden
SE004
Falun, Sweden, 791 30
SE002
Halmstad, Sweden, 30248
SE003
Kungens Kurva, Sweden, 14175
SE001
Lund, Sweden, 222 22
SE006
Stockholm, Sweden, 11486
United Kingdom
GB003
Blackpool, United Kingdom, FY2 0JH
GB002
Bradford, United Kingdom, BD3 0QD
GB001
Manchester, United Kingdom, M32 0UT
GB004
Oxford, United Kingdom, OX3 7JX

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:	NCT01488071 History of Changes
Other Study ID Numbers:	14178A, 2011-002362-21
Study First Received:	November 29, 2011
Last Updated:	January 17, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Estonia: The State Agency of Medicine Sweden: Medical Products Agency

Keywords provided by H. Lundbeck A/S:

Depression
Multimodal antidepressant

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Stress, Psychological
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents

S 20098
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013