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RecruitingNCT06480383

Efficacy, Safety, and Tolerability of ITI-1284 for anxiety

The registry lists this study as recruiting. Study locations are listed in the United States, in Bulgaria, in Czechia, ... Confirm recruitment at each site. It is testing Efficacy, Safety, and Tolerability of ITI-1284 for anxiety.

AnxietyDrug
In plain English

Key information made simple

What is this study testing?

This study is testing whether ITI-1284 as an Adjunctive Treatment may be useful for people experiencing anxiety.

What would participation involve?

Participants may receive ITI-1284 as an Adjunctive Treatment, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Bulgaria, in Czechia, and in Poland.

Who is it mainly for?

This study appears to be mainly for people with anxiety.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: August 5, 2024
Recruitment status
Recruiting
Enrollment listed in the registry
705
Sponsor
Intra-Cellular Therapies, Inc.
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Bulgaria, Czechia, ...
Age range
Not clearly listed
Official registry ID
NCT06480383
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

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Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Bulgaria · 13 sites
  • Medical Center Sv Dimitar Blagoevgrad
    Blagoevgrad
    Site status: Recruiting
  • Mental Health Center Prof. Dr. Ivan Temkov
    Burgas
    Site status: Recruiting
  • Outpatient care-group practice for specialized psychiatric care Datamed OOD
    Pleven
    Site status: Recruiting
  • Medical Center Mentalcare OOD
    Plovdiv
    Site status: Recruiting
  • Mental Health Center - Rousse
    Rousse
    Site status: Recruiting
  • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
    Sofia
    Site status: Recruiting
  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
    Sofia
    Site status: Recruiting
  • Medical Center Hera EOOD
    Sofia
    Site status: Recruiting
  • Medical Center Intermedica, OOD
    Sofia
    Site status: Recruiting
  • Medical center - VAS OOD
    Targovishte
    Site status: Recruiting
  • Diagnostic Consulting Center Mladost - M Varna 1
    Varna
    Site status: Recruiting
  • Diagnostic Consulting Center Mladost - M Varna
    Varna
    Site status: Recruiting
  • Mental Health Center - Vratsa EOOD
    Vratsa
    Site status: Recruiting
Czechia · 5 sites
  • Medipa S R O
    Brno
    Site status: Recruiting
  • A Shine S R O
    Pilsen
    Site status: Recruiting
  • Clintrial s r o
    Prague
    Site status: Recruiting
  • Medical Services Prague S R O
    Prague
    Site status: Recruiting
  • Institut Neuropsychiatricke pece
    Prague
    Site status: Recruiting
Poland · 6 sites
  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
    Bialystok
    Site status: Recruiting
  • Przychodnia Srodmiescie SP. z o.o.
    Bydgoszcz
    Site status: Recruiting
  • Specjalistyczna Praktyka Lekarska Piotr Zalitacz
    Gorlice
    Site status: Recruiting
  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
    Leszno
    Site status: Recruiting
  • Filip Rybakowski Specjalistyczna Praktyka Lekarska
    Poznan
    Site status: Recruiting
  • Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed
    Torun
    Site status: Recruiting
Serbia · 7 sites
  • Institute of Mental Health Serbia
    Belgrade
    Site status: Recruiting
  • University Clinical Center of Serbia 1
    Belgrade
    Site status: Recruiting
  • University Clinical Center of Serbia
    Belgrade
    Site status: Recruiting
  • University Clinical Hospital Center Dr Dragisa Misovic- Dedi
    Belgrade
    Site status: Recruiting
  • Special Neuropsychiatric Hospital Kovin
    Kovin
    Site status: Recruiting
  • University Clinical Center Kragujevac
    Kragujevac
    Site status: Recruiting
  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
    Novi Kneževac
    Site status: Recruiting
United States · 25 sites
  • Behavioral Research Specialists LLC
    Glendale, California
    Site status: Recruiting
  • Sun Valley Research Center
    Imperial, California
    Site status: Recruiting
  • Synergy East
    Lemon Grove, California
    Site status: Recruiting
  • Excell Research Inc
    Oceanside, California
    Site status: Recruiting
  • NRC Research Institute
    Orange, California
    Site status: Recruiting
  • Anderson Clinical Research
    Redlands, California
    Site status: Recruiting
  • Premier Clinical Research
    Miami, Florida
    Site status: Recruiting
  • Global Medical Institutes
    Miami, Florida
    Site status: Recruiting
  • Miami Dade Medical Research Institute
    Miami, Florida
    Site status: Recruiting
  • Sunshine Medical Solution
    Miami, Florida
    Site status: Recruiting
  • South Florida Research Inc
    Miami Springs, Florida
    Site status: Recruiting
  • K2 Medical Research
    Tampa, Florida
    Site status: Recruiting
  • CenExeli Research LLC
    Atlanta, Georgia
    Site status: Recruiting
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Recruiting
  • Michigan Clinical Research Institute
    Ann Arbor, Michigan
    Site status: Recruiting
  • Bio Behavioral Health
    Toms River, New Jersey
    Site status: Recruiting
  • SPRI Clinical Trials, LLC
    Brooklyn, New York
    Site status: Recruiting
  • Neuro Behavioral Clinical Research
    North Canton, Ohio
    Site status: Recruiting
  • Sooner Clinical Research
    Oklahoma City, Oklahoma
    Site status: Recruiting
  • Lehigh Center for Clinical Research LLC
    Allentown, Pennsylvania
    Site status: Recruiting
  • Suburban Research Associates
    Media, Pennsylvania
    Site status: Recruiting
  • Austin Clinical Trial Partners
    Austin, Texas
    Site status: Recruiting
  • BioBehavioral Research of Austin PC
    Austin, Texas
    Site status: Recruiting
  • Aims Trials LLC
    Plano, Texas
    Site status: Recruiting
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Recruiting
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with anxiety. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving ITI-1284 10 mg, ITI-1284 20 mg, Placebo. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with anxiety. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Intra-Cellular Therapies, Inc., which appears to be another type of organization. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

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