ClinicalTrials.gov processed this data on March 27, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT01156415CAGO178C2399NCT01156415Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)Novartis PharmaceuticalsIndustry
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under
the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder
over a 52-week open-label phase.
Cohort I is restricted to include patients who have completed a previous Novartis agomelatine
(178C) Double-blind study.
Cohort II will include de-novo patients (those who did not participate in a previous
agomelatine 178C study) and will only be open for a limited time span ranging from
approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
TerminatedJune 2010October 2011October 2011Phase 3InterventionalNoNon-RandomizedParallel AssignmentTreatmentNone (Open Label)Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale52 weeksChange from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating ScaleWeek 6, 8, 12, 28, 36 and 52Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scaleWeek 6, 8, 12, 28, 36 and 52Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52Week 52Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52Week 522837Major Depressive DisorderAgomelatine (AGO178) 0.5 mgExperimentalAgomelatine (AGO178) 1 mgExperimentalDrugAGO178Agomelatine (AGO178) 1 mgDrugAGO178Agomelatine (AGO178) 0.5 mg
Inclusion Criteria:
Key Inclusion Criteria Cohort I:
- Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
- Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as
for Double-blind Study, but with upper age limit increased by 1-year to accommodate
patients whose age increased during the Double-blind Study).
- Female patients should continue to use effective contraception as defined in
double-blind study protocol.
Inclusion Criteria:
Key Inclusion criteria Cohort II:
- Male and female adults, 18 through 70 years of age, inclusive.
- Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
- Current episode ≥4 weeks.
- CGI-Severity score ≥4 at Screening and Baseline.
Exclusion Criteria:
Key Exclusion Criteria Cohort I:
- Concomitant use of fluvoxamine.
- Any significant medical condition that emerged during Double-blind Phase of a previous
study, which may interfere with study participation and/or study assessments as
assessed by the investigator.
Exclusion Criteria:
Key Exclusion criteria Cohort II:
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating
disorder (current or during previous one year), obsessive-compulsive disorder.
- Any other current Axis I disorder other than MDD which is the focus of treatment.
- Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
- Prior exposure to agomelatine.
- Female patients of childbearing potential who are not using effective contraception.
Other protocol-defined inclusion/exclusion criteria may apply.
All18 Years71 YearsNoNovartis PharmaceuticalsStudy DirectorNovartis PharmaceuticalsUniversity of Alabama at BirminghamBirminghamAlabama35294United StatesAdvanced Research AssociatesGlendaleArizona85308United StatesSouthwest Health Ltd dba The Mollen ClinicScottsdaleArizona85254United StatesClinical Study Centers, LLCLittle RockArkansas72205United StatesSouthwestern Research InstituteBeverly HillsCalifornia90210United StatesComprehensive NeuroscienceCerritosCalifornia90703United StatesATP Clinical Research, IncCosta MesaCalifornia92626United StatesCollaborative Neuroscience NetworkGarden GroveCalifornia92845United StatesPharmacology Research InstituteNewport BeachCalifornia92660United StatesPacific Clinical Research Medical GroupOrangeCalifornia92868United StatesCNRI-San Diego, LLCSan DiegoCalifornia92102United StatesUniversity of California, San Diego Medical CenterSan DiegoCalifornia92103United StatesNeuropsychiatric Research Center of Orange CountySanta AnaCalifornia92701United StatesViking Clinical Research CenterTemeculaCalifornia92591United StatesCollaborative NeuroscienceTorranceCalifornia90502United StatesUniversity of ColoradoAuroraColorado80045United StatesWestern Affiliated Research InstituteDenverColorado80209United StatesMiddlesex HospitalMiddletownConnecticut06457United StatesClinical StudiesAltamonte SpringsFlorida32701United StatesFlorida Clinical Research Center, LLCBradentonFlorida34208United StatesArocha Research CenterCoral GablesFlorida33134United StatesCNS Clinical ResearchCoral SpringsFlorida33067United StatesSjs Clinical ResearchDestinFlorida32541United StatesMD ClinicalHallandale BeachFlorida33009United StatesCNS HealthcareJacksonvilleFlorida32216United StatesFlorida Clinical Research CenterMaitlandFlorida34201United StatesCNS HealthcareOrlandoFlorida32806United StatesQuantum Lab. at N. Broward Memory Disorder CenterPompano BeachFlorida33064United StatesComprehensive NeuroScience, Inc.Saint PetersburgFlorida33716United StatesMiami Research AssociatesSouth MiamiFlorida33143United StatesJanus Center for Psychiatric ResearchWest Palm BeachFlorida33407United StatesEmory UniversityAtlantaGeorgia30306United StatesAtlanta Center for Medical ResearchAtlantaGeorgia30308United StatesNorthwest Behavioral Research CenterMariettaGeorgia30060United StatesHawaii Clinical Research CenterHonoluluHawaii96813United StatesAlexian Brothers Center for Psychiatric ResearchHoffman EstatesIllinois60169United StatesJoliet Center for Clinical ResearchJolietIllinois60435United StatesCapstone Clinical ResearchLibertyvilleIllinois60048United StatesRush University Medical CenterSkokieIllinois60076United StatesDeaconess Clinic GatewayNewburghIndiana47630United StatesPharmasite ResearchPikesvilleMaryland21208United StatesBoston Clinical TrialsBostonMassachusetts02135United StatesMount Auburn Medical AssociatesWatertownMassachusetts02472United StatesCoastal Research AssociatesWeymouthMassachusetts02190United StatesMichigan State UniversityEast LansingMichigan48824United StatesPine Rest Christian Mental Health ServicesGrand RapidsMichigan49548United StatesRochester Center for Behavioral MedicineRochester HillsMichigan48307United StatesComprehensive Psychiatric AssociatesGladstoneMissouri64118United StatesRobert Wood Johnson Medical SchoolPiscatawayNew Jersey08854United StatesBio Behavioral HealthToms RiverNew Jersey08755United StatesCRI WorldwideWillingboroNew Jersey08046United StatesAlbuquerque NeuroscienceAlbuquerqueNew Mexico87109United StatesNeurological Associates Of AlbanyAlbanyNew York12208United StatesMontefiore Medical CenterBronxNew York10467United StatesSocial Psychiatry Research, Inc./ SPRIBrooklynNew York11235United StatesNeurobehavioral Research, Inc.CedarhurstNew York11516United StatesEastside Comprehensive Medical ServiceNew YorkNew York10021United StatesMedical & Behavior Health ResearchNew YorkNew York10023United StatesThe Medical Research Network, LLCNew YorkNew York10128United StatesRichmond Behavioral AssociatesStaten IslandNew York10312United StatesPharmquestGreensboroNorth Carolina27408United StatesZarzar Psychiatric AssociatesRaleighNorth Carolina27607United StatesPiedmont Medical Research Associates, Inc.Winston-SalemNorth Carolina27103United StatesOdyssey Research ServicesFargoNorth Dakota58104United StatesNeuro Behavioral Clinical ResearchCantonOhio44718United StatesUniversity of Cincinnati Medical CenterCincinnatiOhio45219United StatesNorth Star Medical ResearchClevelandOhio44130United StatesThe Ohio State Universtiy - Harding HospitalColumbusOhio43210United StatesNeurology & Neuroscience Center of OhioToledoOhio43623United StatesIPS ResearchOklahoma CityOklahoma73103United StatesSP ResearchOklahoma CityOklahoma73112United StatesCutting Edge ResearchOklahoma CityOklahoma73116United StatesSunstone Medical Research, LLCMedfordOregon97504United StatesOregon Center for Clinical InvestigationsPortlandOregon97210United StatesSummit ResearchPortlandOregon97210United StatesLehigh Center for Clinical ResearchAllentownPennsylvania18104United StatesSuburban Research AssociatesMediaPennsylvania19063United StatesCRI Worldwide, LLCPhiladelphiaPennsylvania19139United StatesMedical University of South CarolinaCharlestonSouth Carolina29406United StatesClinical Neuroscience Solutions, Inc.MemphisTennessee38119United StatesResearch Strategies of MemphisMemphisTennessee38119United StatesClinical Research AssociatesNashvilleTennessee37203United StatesMillwood HospitalArlingtonTexas76011United StatesFutureSearch Trials of DallasDallasTexas75231United StatesInSite Clinical ResearchDeSotoTexas75115United StatesBayou City Research LimitedHoustonTexas77007United StatesClaghorn Lesem Research Clinic, Inc.HoustonTexas77008United StatesTexas Center for Drug DevelopmentHoustonTexas77081United StatesGrayline Clinical Drug TrialsWichita FallsTexas76309United StatesRadiant ResearchSalt Lake CityUtah84107United StatesUniversity of Utah Mood Disorders ClinicSalt Lake CityUtah84132United StatesAlliance Research Group, LLCRichmondVirginia23230United StatesNorthwest Clinical Research CenterBellevueWashington98007United StatesFrontier InstituteSpokaneWashington99204United StatesIndependent Psychiatric ConsultantsWaukeshaWisconsin53188United StatesCentro de Investigacion Clinica PsiquiatricaPonce00731Puerto RicoDharma Institute and Research CenterSan Juan00907Puerto RicoINSPIRA Clinical ResearchSan Juan00918Puerto RicoPuerto RicoUnited Stateshttps://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7243Results for CAGO178C2399 from the Novartis Clinical Trials websiteMarch 2013June 30, 2010July 1, 2010July 2, 2010February 14, 2013February 14, 2013February 20, 2013December 16, 2020December 16, 2020December 24, 2020SponsoragomelatineMajor Depressive DisorderMDDdepressionDepressive DisorderDepressionDepressive Disorder, MajorAgomelatine