Phase
Condition
Depression
Depression (Major/severe)
Depression (Adult And Geriatric)
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient is an outpatient consulting a psychiatrist.
The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major DepressiveEpisode (MDE) should be confirmed using the Mini International NeuropsychiatricInterview (MINI).
The patient has a moderate to severe depression and an insufficient response to atleast one and no more than three adequate antidepressant treatments.
The patient agrees to protocol-defined use of effective contraception.
Exclusion
Exclusion Criteria:
The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™criteria), established as the primary diagnosis, other than MDD.
The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial,paranoid, schizoid, schizotypical or histrionic personality disorder.
The patient has experienced/experiences hallucinations, delusions or any psychoticsymptomatology in the current MDE.
The patient suffers from mental retardation, organic mental disorders, or mentaldisorders due to a general medical condition (DSM-IV-TR™ criteria).
The patient, in the opinion of the investigator or according to Columbia-SuicideSeverity Rating Scale (C-SSRS), is at significant risk of suicide.
The patient has had neuroleptic malignant syndrome.
The patient has any relevant medical history or current presence of systemic disease.
The patient has, at the Screening Visit an abnormal ECG that is, in the investigator'sopinion, clinically significant.
The patient has a history of cancer, other than basal cell or Stage 1 squamous cellcarcinoma of the skin, that has not been in remission for >5 years prior to the firstdose of IMP.
The patient is, in the investigator's opinion, unlikely to comply with the protocol oris unsuitable for any reason. Other inclusion and exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
BG007
Kardjali,
BulgariaSite Not Available
BG002
Pazardzhik,
BulgariaSite Not Available
BG003
Ruse,
BulgariaSite Not Available
BG001
Sofia,
BulgariaSite Not Available
BG004
Sofia,
BulgariaSite Not Available
BG005
Varna,
BulgariaSite Not Available
BG006
Varna,
BulgariaSite Not Available
CA003
Burlington,
CanadaSite Not Available
CA004
Edmonton, Alberta,
CanadaSite Not Available
CA001
Kingston,
CanadaSite Not Available
CA002
Montral,
CanadaSite Not Available
CA005
Montreal,
CanadaSite Not Available
EE002
Tallinn,
EstoniaSite Not Available
EE003
Tallinn,
EstoniaSite Not Available
EE006
Tallinn,
EstoniaSite Not Available
EE001
Tartu,
EstoniaSite Not Available
EE005
Tartu,
EstoniaSite Not Available
EE004
Voru,
EstoniaSite Not Available
FI002
Helsinki,
FinlandSite Not Available
FI003
Helsinki,
FinlandSite Not Available
FI006
Helsinki,
FinlandSite Not Available
FI001
Kuopio,
FinlandSite Not Available
FI007
Pori,
FinlandSite Not Available
FI009
Tampere,
FinlandSite Not Available
DE007
Berlin,
GermanySite Not Available
DE014
Berlin,
GermanySite Not Available
DE015
Berlin,
GermanySite Not Available
DE006
Bielefeld,
GermanySite Not Available
DE010
Bochum,
GermanySite Not Available
DE012
Gelsenkirchen,
GermanySite Not Available
DE009
Hannover,
GermanySite Not Available
DE022
Hattingen,
GermanySite Not Available
DE008
Heidelberg,
GermanySite Not Available
DE017
Leipzig,
GermanySite Not Available
DE001
Nuernberg,
GermanySite Not Available
DE004
Nuernberg,
GermanySite Not Available
DE002
Schwerin,
GermanySite Not Available
DE016
Wiesbaden,
GermanySite Not Available
IT001
Brescia,
ItalySite Not Available
KR009
Bucheon-si,
Korea, Republic ofSite Not Available
KR008
Gwangju,
Korea, Republic ofSite Not Available
KR002
Incheon,
Korea, Republic ofSite Not Available
KR007
Seongnam-si,
Korea, Republic ofSite Not Available
KR001
Seoul,
Korea, Republic ofSite Not Available
KR004
Seoul,
Korea, Republic ofSite Not Available
LV004
Daugavpils,
LatviaSite Not Available
LV005
Jelgava,
LatviaSite Not Available
LV002
Liepaja,
LatviaSite Not Available
LV003
Riga,
LatviaSite Not Available
LV001
Strenci,
LatviaSite Not Available
LT003
Kaunas,
LithuaniaSite Not Available
LT006
Kaunas Region,
LithuaniaSite Not Available
LT001
Palanga,
LithuaniaSite Not Available
LT005
Silute,
LithuaniaSite Not Available
LT002
Vilnius,
LithuaniaSite Not Available
LT004
Vilnius,
LithuaniaSite Not Available
MX009
Guadalajara,
MexicoSite Not Available
MX008
Leon,
MexicoSite Not Available
MX002
Monterrey,
MexicoSite Not Available
MX003
Monterrey, Nuevo Len,
MexicoSite Not Available
PL010
Bialystok,
PolandSite Not Available
PL016
Bialystok,
PolandSite Not Available
PL017
Bydgoszcz,
PolandSite Not Available
PL007
Chelmno,
PolandSite Not Available
PL002
Gdansk,
PolandSite Not Available
PL011
Gorlice,
PolandSite Not Available
PL018
Kielce,
PolandSite Not Available
PL013
Leszno,
PolandSite Not Available
PL001
Lublin,
PolandSite Not Available
PL006
Lublin,
PolandSite Not Available
PL004
Skorzewo,
PolandSite Not Available
PL014
Szczecin,
PolandSite Not Available
PL012
Torun,
PolandSite Not Available
PL019
Torun,
PolandSite Not Available
RO003
Bucuresti,
RomaniaSite Not Available
RO006
Bucuresti,
RomaniaSite Not Available
RO001
Iasi,
RomaniaSite Not Available
RO004
Timisoara,
RomaniaSite Not Available
RU002
Moscow,
Russian FederationSite Not Available
RU004
Moscow,
Russian FederationSite Not Available
RU003
Saint-Petersburg,
Russian FederationSite Not Available
RU006
Saint-Petersburg,
Russian FederationSite Not Available
RU007
Saint-Petersburg,
Russian FederationSite Not Available
RU010
Saint-Petersburg,
Russian FederationSite Not Available
RU014
Saint-Petersburg,
Russian FederationSite Not Available
RU012
Saratov,
Russian FederationSite Not Available
RU005
Stavropol,
Russian FederationSite Not Available
SE008
Halmstad,
SwedenSite Not Available
SE006
Malm,
SwedenSite Not Available
SE006
Malmo,
SwedenSite Not Available
SE009
Skovde,
SwedenSite Not Available
SE001
Stockholm,
SwedenSite Not Available
UA006
Kharkiv,
UkraineSite Not Available
UA007
Kherson,Vil. Stepanivka,
UkraineSite Not Available
UA003
Kiev,
UkraineSite Not Available
UA014
Kiev,
UkraineSite Not Available
UA002
Kyiv,
UkraineSite Not Available
UA005
Lviv,
UkraineSite Not Available
UA012
Ternopil,
UkraineSite Not Available
UA009
Vinnytsya,
UkraineSite Not Available
GB003
Blackpool,
United KingdomSite Not Available
GB005
Bognor Regis,
United KingdomSite Not Available
GB002
Bradford,
United KingdomSite Not Available
GB004
Cannock,
United KingdomSite Not Available
GB001
Leeds,
United KingdomSite Not Available
GB006
Winwick,
United KingdomSite Not Available
US041
Little Rock, Arkansas
United StatesSite Not Available
US043
Cerritos, California
United StatesSite Not Available
US042
Temecula, California
United StatesSite Not Available
US042
Ternecula, California
United StatesSite Not Available
US053
Flowood, Mississippi
United StatesSite Not Available
US040
Brooklyn, New York
United StatesSite Not Available
US046
Houston, Texas
United StatesSite Not Available
US052
Houston, Texas
United StatesSite Not Available
US044
Herndon, Virginia
United StatesSite Not Available
US047
Milwaukee, Wisconsin
United StatesSite Not Available
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