Studie av ITI-1284 som tilleggsbehandling hos pasienter med generalisert angstlidelse
En multisenter, randomisert, dobbeltblind, placebokontrollert studie for å vurdere effektiviteten, sikkerheten og toleransen til ITI-1284 som tilleggsbehandling hos pasienter med generalisert angstlidelse som har en utilstrekkelig respons på behandling med generalisert angstlidelse
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Blagoevgrad, Bulgaria, 2700
- Rekruttering
- Medical Center Sv Dimitar Blagoevgrad
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Burgas, Bulgaria, 8001
- Rekruttering
- Mental Health Center Prof. Dr. Ivan Temkov
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Pleven, Bulgaria, 5800
- Rekruttering
- Outpatient care-group practice for specialized psychiatric care Datamed OOD
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Plovdiv, Bulgaria, 4004
- Rekruttering
- Medical Center Mentalcare OOD
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Rousse, Bulgaria, 7003
- Rekruttering
- Mental Health Center - Rousse
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Sofia, Bulgaria, 1680
- Rekruttering
- Medical Center Intermedica, OOD
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Sofia, Bulgaria, 1408
- Rekruttering
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, Bulgaria, 1510
- Rekruttering
- Medical Center Hera EOOD
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Sofia, Bulgaria, 1113
- Rekruttering
- Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
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Targovishte, Bulgaria, 7700
- Rekruttering
- Medical center - VAS OOD
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Varna, Bulgaria, 9020
- Rekruttering
- Diagnostic Consulting Center Mladost - M Varna
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Varna, Bulgaria, 9020
- Rekruttering
- Diagnostic Consulting Center Mladost - M Varna 1
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Vratsa, Bulgaria, 3000
- Rekruttering
- Mental Health Center - Vratsa EOOD
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Kuopio, Finland, 70110
- Rekruttering
- Savon Psykiatripalvelu
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Oulu, Finland, 90100
- Rekruttering
- Oulu Mentalcare Oy
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Tampere, Finland, 33210
- Rekruttering
- Satakunnan Psykiatripalvelu Oy at Mehilainen Oy
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California
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Glendale, California, Forente stater, 91206
- Rekruttering
- Behavioral Research Specialists LLC
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Imperial, California, Forente stater, 92251
- Rekruttering
- Sun Valley Research Center
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Lemon Grove, California, Forente stater, 91945
- Rekruttering
- Synergy East
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Oceanside, California, Forente stater, 92056
- Rekruttering
- Excell Research Inc
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Orange, California, Forente stater, 92868
- Rekruttering
- NRC Research Institute
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Redlands, California, Forente stater, 92374
- Rekruttering
- Anderson Clinical Research
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Florida
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Miami, Florida, Forente stater, 33176
- Rekruttering
- Miami Dade Medical Research Institute
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Miami, Florida, Forente stater, 33122
- Rekruttering
- Premier Clinical Research
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Miami, Florida, Forente stater, 33125
- Rekruttering
- Global Medical Institutes
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Miami, Florida, Forente stater, 33186
- Rekruttering
- Sunshine Medical Solution
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Miami Springs, Florida, Forente stater, 33166
- Rekruttering
- South Florida Research Inc
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Tampa, Florida, Forente stater, 33634
- Rekruttering
- K2 Medical Research
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Georgia
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Atlanta, Georgia, Forente stater, 30331
- Rekruttering
- Atlanta Center for Medical Research
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Atlanta, Georgia, Forente stater, 30030
- Rekruttering
- CenExeli Research LLC
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Michigan
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Ann Arbor, Michigan, Forente stater, 48105
- Rekruttering
- Michigan Clinical Research Institute
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New Jersey
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Toms River, New Jersey, Forente stater, 08755
- Rekruttering
- Bio Behavioral Health
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New York
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Brooklyn, New York, Forente stater, 11235
- Rekruttering
- SPRI Clinical Trials, LLC
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Ohio
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North Canton, Ohio, Forente stater, 44720
- Rekruttering
- Neuro Behavioral Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73120
- Rekruttering
- Sooner Clinical Research
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18103
- Rekruttering
- Lehigh Center for Clinical Research LLC
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Media, Pennsylvania, Forente stater, 19063
- Rekruttering
- Suburban Research Associates
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Texas
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Austin, Texas, Forente stater, 78737
- Rekruttering
- Austin Clinical Trial Partners
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Austin, Texas, Forente stater, 78759
- Rekruttering
- BioBehavioral Research of Austin PC
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Plano, Texas, Forente stater, 75093
- Rekruttering
- Aims Trials LLC
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Washington
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Bellevue, Washington, Forente stater, 98007
- Rekruttering
- Northwest Clinical Research Center
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Bialystok, Polen, 15-404
- Rekruttering
- Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
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Bydgoszcz, Polen, 85-080
- Rekruttering
- Przychodnia Srodmiescie SP. z o.o.
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Gorlice, Polen, 38-300
- Rekruttering
- Specjalistyczna Praktyka Lekarska Piotr Zalitacz
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Leszno, Polen, 64-100
- Rekruttering
- Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
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Poznan, Polen, 60 744
- Rekruttering
- Filip Rybakowski Specjalistyczna Praktyka Lekarska
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Torun, Polen, 87 100
- Rekruttering
- Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed
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Belgrade, Serbia, 11000
- Rekruttering
- University Clinical Center of Serbia
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Belgrade, Serbia, 11000
- Rekruttering
- Institute of Mental Health Serbia
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Belgrade, Serbia, 11000
- Rekruttering
- University Clinical Hospital Center Dr Dragisa Misovic- Dedi
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Belgrade, Serbia, 11000
- Rekruttering
- University Clinical Center of Serbia 1
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Kovin, Serbia, 26220
- Rekruttering
- Special Neuropsychiatric Hospital Kovin
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Kragujevac, Serbia, 34000
- Rekruttering
- University Clinical Center Kragujevac
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Novi Kneževac, Serbia, 23330
- Rekruttering
- Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
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Brno, Tsjekkia, 60200
- Rekruttering
- Medipa S R O
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Pilsen, Tsjekkia, 301 00
- Rekruttering
- A Shine S R O
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Prague, Tsjekkia, 10000
- Rekruttering
- Clintrial s r o
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Prague, Tsjekkia, 16000
- Rekruttering
- Medical Services Prague S R O
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Prague, Tsjekkia, 18600
- Rekruttering
- Institut Neuropsychiatricke pece
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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Provide written informed consent before the initiation of any study specific procedures;
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Male or female patients ≥ 18 years of age;
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At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:
- HAM-A Total score of ≥ 22;
- HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
- CGI-S score of ≥ 4;
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History of inadequate response (< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to at least 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 milligrams [mg], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;
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Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.
NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.
Exclusion Criteria:
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Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
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MADRS total score > 18 at Screening or Baseline;
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In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
- At Screening or Baseline MADRS Item 10 score ≥ 5; or
- The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.
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Lifetime history of failure to respond to > 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
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Matching placebo tablet, taken once daily, sublingual administration |
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Eksperimentell: ITI-1284 10 mg
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ITI-1284 10 mg tablet, taken once daily, sublingual administration. |
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Eksperimentell: ITI-1284 20 mg
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ITI-1284 20 mg tablet, taken once daily, sublingual administration. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hamilton Anxiety Rating Scale (HAM-A)
Tidsramme: Week 6
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The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It comprises of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms. |
Week 6
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Global Impression Scale-Severity (CGI-S)
Tidsramme: Week 6
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The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients) |
Week 6
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Intra-Cellular Therapies,Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ITI-1284-301
- 2024-513302-56-00 (Registeridentifikator: EUCT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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