Clinical trial • Phase III • Psychiatry
DIRECLIDINE for Schizophrenia|Acute schizophrenia
Phase III trial of DIRECLIDINE for Schizophrenia|Acute schizophrenia.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Schizophrenia|Acute schizophrenia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-07-2025
- First CTIS Authorization Date
- 07-11-2025
Trial design
Randomised, nbi-1117568 placebo capsule (placebo comparator). dose and schedule not specified in the available documents.-controlled Phase III trial across 15 sites in Bulgaria, Romania, Hungary.
- Randomised
- Yes
- Comparator
- NBI-1117568 Placebo Capsule (placebo comparator). Dose and schedule not specified in the available documents.
- Target Sample Size
- 143
Eligibility
Recruits 143 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be adults (≥18). Subject information and informed consent forms (L1 SIS and ICF) and Designated Study Partner ICFs are provided (documents in multiple languages listed)..
- Pregnancy Exclusion
- Pregnant or breastfeeding.
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Participants must be adults (≥18). Subject information and informed consent forms (L1 SIS and ICF) and Designated Study Partner ICFs are provided (documents in multiple languages listed).
Inclusion criteria
- {"criterion_text":"-≥18 and ≤65 years of age."}
- {"criterion_text":"-Primary diagnosis of schizophrenia."}
- {"criterion_text":"-Experiencing a sudden worsening or relapse of symptoms starting <2 months before screening and currently warrants hospitalization."}
Exclusion criteria
- {"criterion_text":"-Considered to be at imminent risk of suicide or injury to self or others."}
- {"criterion_text":"-Any unstable or poorly controlled medical condition or chronic disease."}
- {"criterion_text":"-Any laboratory test results indicating clinically significant, poorly managed, or unmanaged undiagnosed disease."}
- {"criterion_text":"-Certain heart conditions or uncontrolled blood pressure."}
- {"criterion_text":"-History of epilepsy, seizures (except seizures during childhood caused by a fever), or convulsions."}
- {"criterion_text":"-Currently taking medications that are not allowed."}
- {"criterion_text":"-Pregnant or breastfeeding."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Change from baseline in PANSS total score at Week 5","definition_or_measurement_approach":"Change from baseline (baseline defined as the day before first dose) in PANSS total score at Week 5; PANSS = Positive and Negative Syndrome Scale."}
Secondary endpoints
- {"endpoint_text":"-Change from baseline in CGI-S score at Week 5","definition_or_measurement_approach":"Change from baseline in Clinical Global Impression - Severity (CGI-S) score at Week 5."}
Recruitment
- Planned Sample Size
- 143
- Recruitment Window Months
- 27
- Consent Approach
- Participants are adults (≥18). Informed consent obtained via Subject Information Sheets and Informed Consent Forms (L1 SIS and ICF documents). Designated Study Partner ICFs and Pregnancy Follow-up Authorization ICFs are available. ICF documents are available in multiple languages (English, Romanian, Hungarian, Bulgarian as indicated by document titles). Assent is not applicable (adult-only population).
Methods
- Recruitment arrangements documents (titles include K1_Recruitment Arrangements and country-specific K1_Romania_Recruitment Arrangements) are provided (specific channels/details not stated).
- GP letters referenced in recruitment documents (titles include K2_GP Letter_Redacted and GP Letter documents for Romania) are provided (specific distribution channels not specified).
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 141
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 25-09-2025
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 46
- Number Of Sites
- 4
- Number Of Participants
- 57
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- First Psychiatric Clinic - Psychiatry
- Contact Person Name
- Maya Popova
- Contact Person Email
- dr.maya.stoimenova@gmail.com
- Site Name
- MBAL Dr. Ivan Seliminski - Sliven AD
- Department Name
- Psychiatry
- Contact Person Name
- Rozalina Petrova
- Contact Person Email
- dr.rozalina.petrova@gmail.com
- Site Name
- Center For Mental Health Vratsa EOOD
- Department Name
- Department of General Psychiatry
- Contact Person Name
- Nadya Ivanova
- Contact Person Email
- nadia_odpzs@abv.bg
- Site Name
- State Psychiatric Hospital Tserova Koria
- Department Name
- Department for Active Treatment of Severe Psychosis – males and females
- Contact Person Name
- Stoyan Zdravkov
- Contact Person Email
- szdravkov@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 06-10-2025
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 35
- Number Of Sites
- 6
- Number Of Participants
- 83
Sites
- Site Name
- Spitalul Clinic De Psihiatrie Si Neurologie Brasov
- Department Name
- Psychiatry II Clinical Department
- Contact Person Name
- Ana Aliana Miron
- Contact Person Email
- relatiicupublicul@spnbrasov.ro
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psychiatry I Clinical Department
- Contact Person Name
- Ana Anca Chendea
- Contact Person Email
- secretariat@spital-obregia
- Site Name
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
- Department Name
- Psychiatry Clinical Department
- Contact Person Name
- Traian-Liciniu Barbu
- Contact Person Email
- cettt_sf.stelian@yahoo.com
- Site Name
- Institutul De Psihiatrie Socola Iasi
- Department Name
- Psychiatry III Clinical Department
- Contact Person Name
- Serban Turliuc
- Contact Person Email
- secretariat@socola.eu
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psychiatry IX Clinical Department
- Contact Person Name
- Adela Magdalena Ciobanu
- Contact Person Email
- secretariat@spital-obregia
- Site Name
- Spitalul Clinic De Psihiatrie Si Neurologie Brasov
- Department Name
- Psychiatry III Clinical Department
- Contact Person Name
- Petru-Iulian Ifteni
- Contact Person Email
- relatiicupublicul@spnbrasov.ro
Hungary
- Earliest CTIS Part Ii Submission Date
- 11-09-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 144
- Number Of Sites
- 5
- Number Of Participants
- 1
Sites
- Site Name
- Gyoengyosi Bugat Pal Koerhaz
- Department Name
- Psychiatry
- Contact Person Name
- Tibor Kelemen
- Contact Person Email
- tibor.kelemen.clinexpert@gmail.com
- Site Name
- Clinexpert Kft.
- Contact Person Name
- Tiberiu Dina
- Contact Person Email
- dinatibi@yahoo.com
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Psychiatry
- Contact Person Name
- Eva Mathe
- Contact Person Email
- matheevazs@gmail.com
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Psychiatry, Mentalhygiene and Addictology
- Contact Person Name
- Gabor Feller
- Contact Person Email
- fellerg@petz.gyor.hu
- Site Name
- Semmelweis University
- Department Name
- Psychiatry and Psychotheraphy
- Contact Person Name
- Csilla Bolyos
- Contact Person Email
- bolyos.csilla@semmelweis.hu
Sponsor
Primary sponsor
- Full Name
- Neurocrine Biosciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Sudova LLC
- Responsibilities
- code: 3
- Name
- Premier Research International LLC
- Responsibilities
- codes: 1,12,13,2,5 (multiple study operational responsibilities listed)
- Name
- Verified Clinical Trials LLC
- Responsibilities
- Determine if the potential patients have/are participated/participating in another trial
- Name
- Syneos Health Inc.
- Responsibilities
- PK testing
- Name
- Cronos Clinical Consulting Services, Inc.
- Responsibilities
- Rater training/ Scales management
- Name
- Clario Medical Imaging Inc.
- Responsibilities
- Central ECG reader
- Name
- Medidata Solutions Inc.
- Responsibilities
- Electronic data platform/helpdesk support
- Name
- Cytel Inc.
- Responsibilities
- Data Monitoring Committee Charter
Third parties
- {"country":"United States","full_name":"Sudova LLC","duties_or_roles":"code: 3","organisation_type":"Industry"}
- {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"code: 15; value: Genpotyping","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Etymax Limited","duties_or_roles":"code: 15; value: Translations of study documents","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"code: 15; value: Central ECG reader","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Premier Research International LLC","duties_or_roles":"codes: 1,12,13,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Verified Clinical Trials LLC","duties_or_roles":"code: 15; value: Determine if the potential patients have/are participated/participating in another trial","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code: 15; value: PK testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"code: 15; value: Data Monitoring Commitee Charter","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Labor Dr. Wisplinghoff GbR","duties_or_roles":"code: 15; value: General lab","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Cronos Clinical Consulting Services, Inc.","duties_or_roles":"code: 15; value: Rater training/ Scales management","organisation_type":"Industry"}
- {"country":"United Kingdom","full_name":"YES Print","duties_or_roles":"code: 15; value: Printing","organisation_type":"SME"}
- {"country":"United States","full_name":"Clinical365 LLC","duties_or_roles":"code: 15; value: Study supplies","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- NBI-1117568
- Active Substance
- DIRECLIDINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- MIA number: IMP11566/00001;2024_035_1-2; DE_BB_01_MIA_2024_0015
- Investigational Product Name
- NBI-1117568
- Active Substance
- DIRECLIDINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- MIA number: IMP11566/00001;2024_035_1-2; DE_BB_01_MIA_2024_0015
- Investigational Product Name
- NBI-1117568 Placebo Capsule
- Modality
- Other
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