A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

Last updated: February 11, 2014
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

3

Condition

Depression

Depression (Major/severe)

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT01488071
14178A
2011-002362-21
  • Ages 18-75
  • All Genders

Study Summary

The objective of the present study is to evaluate whether vortioxetine (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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TRcriteria)

  • The response to the current SRI treatment is inadequate and patient agrees todiscontinue the current SRI at the baseline

  • Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the ScreeningVisit 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

Exclusion Criteria:

  • The patient has any current Axis I disorders (DSM-IV criteria) other than MajorDepressive Disorder (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 psychoactivemedications Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Total Participants: 495
Study Start date:
January 01, 2012
Estimated Completion Date:

Connect with a study center

  • AT004

    Neunkirchen, 2620
    Austria

    Site Not Available

  • AT003

    Vienna, 1010
    Austria

    Site Not Available

  • BE001

    Brugge, 8310
    Belgium

    Site Not Available

  • BE003

    Sint-Niklaas, 9100
    Belgium

    Site Not Available

  • BG001

    Bourgas, 8000
    Bulgaria

    Site Not Available

  • BG002

    Pazardzhik, 4400
    Bulgaria

    Site Not Available

  • BG003

    Sofia,
    Bulgaria

    Site Not Available

  • BG004

    Varna, 90110
    Bulgaria

    Site Not Available

  • CZ003

    Brno, 602 00
    Czech Republic

    Site Not Available

  • CZ005

    Olomouc, 779 00
    Czech Republic

    Site Not Available

  • CZ006

    Praha, 10000
    Czech Republic

    Site Not Available

  • CZ009

    Praha 1, 11000
    Czech Republic

    Site Not Available

  • CZ008

    Praha 10, 10000
    Czech Republic

    Site Not Available

  • CZ002

    Praha 6, 16000
    Czech Republic

    Site Not Available

  • CZ010

    Praha 9, 19000
    Czech Republic

    Site Not Available

  • EE003

    Parnu, 80012
    Estonia

    Site Not Available

  • EE001

    Tallinn, 10617
    Estonia

    Site Not Available

  • EE004

    Tartu, 50417
    Estonia

    Site Not Available

  • DE005

    Berlin, 10245
    Germany

    Site Not Available

  • DE004

    Gelsenkirchen, 45879
    Germany

    Site Not Available

  • DE003

    Heidelberg, 69115
    Germany

    Site Not Available

  • DE001

    Leipzig, 04159
    Germany

    Site Not Available

  • IT001

    Milan, 20122
    Italy

    Site Not Available

  • IT002

    Turin, 10126
    Italy

    Site Not Available

  • LT003

    Kaunas, 50185
    Lithuania

    Site Not Available

  • LT004

    Klaipeda, 91251
    Lithuania

    Site Not Available

  • LT006

    Palanga, 00135
    Lithuania

    Site Not Available

  • LT002

    Vilnius, 10204
    Lithuania

    Site Not Available

  • PL001

    Gdansk, 80-542
    Poland

    Site Not Available

  • PL002

    Gdynia, 81-361
    Poland

    Site Not Available

  • PL008

    Gorlice, 38-300
    Poland

    Site Not Available

  • PL007

    Lublin, 20-109
    Poland

    Site Not Available

  • PL003

    Skorzewo, 60-185
    Poland

    Site Not Available

  • PL005

    Torun, 87-100
    Poland

    Site Not Available

  • PL010

    Tuszyn, 95-080
    Poland

    Site Not Available

  • RO005

    Arad, 310022
    Romania

    Site Not Available

  • RO002

    Bucharest, 041914
    Romania

    Site Not Available

  • RO001

    Craiova, 200260
    Romania

    Site Not Available

  • RO007

    Focsani, 620165
    Romania

    Site Not Available

  • RU001

    Ekaterinburg, 620030
    Russian Federation

    Site Not Available

  • RU008

    Lipetsk, 398007
    Russian Federation

    Site Not Available

  • RU002

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • RU004

    Saratov, 410028
    Russian Federation

    Site Not Available

  • RU014

    St Petersburg, 192019
    Russian Federation

    Site Not Available

  • RU005

    St. Petersburg, 191119
    Russian Federation

    Site Not Available

  • RU009

    St.Petersburg, 192019
    Russian Federation

    Site Not Available

  • RU003

    Tomsk, 634014
    Russian Federation

    Site Not Available

  • RU013

    Tonnel'nyy, 357034
    Russian Federation

    Site Not Available

  • ES003

    Alcoy Alicante, 03804
    Spain

    Site Not Available

  • ES006

    Barcelona, 08003
    Spain

    Site Not Available

  • ES007

    Madrid, 08029
    Spain

    Site Not Available

  • ES002

    Palma de Mallorca, 07010
    Spain

    Site Not Available

  • ES004

    Sabadell Barcelona, 08208
    Spain

    Site Not Available

  • SE004

    Falun, 791 30
    Sweden

    Site Not Available

  • SE002

    Halmstad, 30248
    Sweden

    Site Not Available

  • SE003

    Kungens Kurva, 14175
    Sweden

    Site Not Available

  • SE001

    Lund, 222 22
    Sweden

    Site Not Available

  • SE006

    Stockholm, 11486
    Sweden

    Site Not Available

  • GB003

    Blackpool, FY2 0JH
    United Kingdom

    Site Not Available

  • GB002

    Bradford, BD3 0QD
    United Kingdom

    Site Not Available

  • GB001

    Manchester, M32 0UT
    United Kingdom

    Site Not Available

  • GB004

    Oxford, OX3 7JX
    United Kingdom

    Site Not Available

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