A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment and an Open-label Long-term Extension Treatment With JNJ-99245354 (ITI-1284)
The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Study Contact
- Puhelinnumero: 844-434-4210
- Sähköposti: Participate-In-This-Study1@its.jnj.com
Opiskelupaikat
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California
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Temecula, California, Yhdysvallat, 92591
- Rekrytointi
- Inland Psychiatric Medical Group Inc
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Florida
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Miami, Florida, Yhdysvallat, 33186
- Rekrytointi
- Nuovida Research Center
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Massachusetts
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Springfield, Massachusetts, Yhdysvallat, 01103
- Rekrytointi
- Voltaire Clinical Research
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New York
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New York, New York, Yhdysvallat, 10017
- Rekrytointi
- Fieve Clinical Research Inc
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion criteria:
- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at baseline
- Medically stable on the basis of clinical laboratory tests performed at screening
- History of inadequate response to at least 1 generalized anxiety disorder (GAD)-approved treatment taken at an adequate dose and duration as specified in the protocol for the treatment of ongoing GAD symptoms
- Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the double blind (DB) treatment period of the trial
- Body mass index (BMI) within the range 19-40 kilogram per meter squared (kg/m^2) (inclusive)
Exclusion criteria:
- Within the participant's lifetime, has one of the following confirmed diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) text revision (TR) psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
- Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders (except simple phobias and social anxiety disorder); b. moderate or severe alcohol or substance use disorders (excluding nicotine); d. moderate or severe major depressive disorder; e. any other psychiatric condition (except for mild major depressive disorder [MDD]) that has been the main focus of treatment
- Montgomery-asberg depression rating scale (MADRS) total score greater than (>)18 at screening or baseline
- Lifetime history of inadequate response to >3 of the approved treatments for GAD at an adequate dose and for an adequate duration
- The participant is taking more than 1 anti depressive therapy (ADT) or is taking ADT + buspirone at screening, regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to baseline
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: JNJ-99245354: Dose 1
Participants will receive JNJ-99245354 dose 1 as an adjunctive therapy once daily for up to 6 weeks in the double blind (DB) period. Eligible participants can enter the open-label (OL) period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks. |
JNJ-99245354 will be administered sublingually.
Muut nimet:
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Kokeellinen: JNJ-99245354: Dose 2
Participants will receive JNJ-99245354 dose 2 as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks. |
JNJ-99245354 will be administered sublingually.
Muut nimet:
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Placebo Comparator: Placebo
Participants will receive placebo as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks. |
JNJ-99245354 will be administered sublingually.
Muut nimet:
Placebo will be administered sublingually. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change from Baseline to End of Week 6 in Hamilton Anxiety Rating (HAM-A) Scale Total Score
Aikaikkuna: Baseline, 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). Each item is 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 where higher score indicates greater severity in anxiety. |
Baseline, Week 6
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change from Baseline to the End of Week 6 in Clinical Global Impression-Severity (CGI-S) Anxiety Score
Aikaikkuna: Baseline, Week 6
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The CGI-S scale is a standardized assessment tool that the clinician can use to rate the overall severity of illness. The CGI-S asks the clinician: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? CGI-S is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Here, higher score indicates higher symptom severity. |
Baseline, Week 6
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Change from Baseline to the End of Week 1 in HAM-A Total Score
Aikaikkuna: Baseline, Week 1
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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). Each item is 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 where higher score indicates greater severity in anxiety. |
Baseline, Week 1
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 99245354ANX3001
- 2026-527319-40-00 (Rekisterin tunniste: EUCT number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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