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CLOZAPINE Response in Biotype-1

StatusRecruiting
PhasePhase 4
Started2022-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-05-07
Study Status v19
Primary completion pushed: 2026-04-01 → 2027-04-30
Completion pushed: 2026-04-01 → 2027-04-30
2026-02-04
Study Status v18
Primary completion date2025-12-31→2026-04-01
Completion date2026-03-31→2026-04-01
2025-08-27
Study Status v17
Re-verified, no change to tracked fields
2024-08-27
Study Status, Contacts/Locations v16
Study sitescontacts updated at 1 of 5 sites
2024-07-29
Study Status, Contacts/Locations v15
Study sites1→5
Show 14 earlier versions
2024-07-16
Study Status, Contacts/Locations v14
Study sitescontacts updated at 1 of 1 site
2024-06-17
Study Status, Contacts/Locations v13
Re-verified, no change to tracked fields
2024-04-01
Study Identification, Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 1 site
Study title-36 characters
AntipsychoticCLOZAPINE Response to Clozapine in B-SNIP Biotype-1 (Clozapine)
2023-03-15
Study Status, Eligibility v11
Primary completion date2024-12→2025-12-31
Completion date2025-09→2026-03-31
Start date2022-01-24→2022-03-01
Eligibility criteriarevised
Inclusion Criteria: 18-50y60y/o; males and females; all races and ethnicities; able to pr [...]
2023-02-14
Study Status v10
Re-verified, no change to tracked fields
2022-02-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-01-15→confirmed 2022-01-24
Study sites0→1
2022-01-03
Study Status v8
Start date2021-11-30→2022-01-15
2021-10-28
Study Status v7
Start date2021-09-30→2021-11-30
2021-08-09
Study Status v6
Completion date2025-07→2025-09
Start date2021-07-15→2021-09-30
2021-05-14
Study Status, Eligibility v5
Eligibility criteria+45 characters
[...] uroleptic malignant syndrome; prior treatment with clozapine or risperidone within the past 1 month, prior treatment with long-acting injectable antipsychotics that are 1-month formulations within the past 3 months and for 3-month formulations within the past 6 months; intolerable side effects to eithe [...]
2021-05-11
Study Status v4
Start date2021-04-15→2021-07-15
2021-03-30
Study Status v3
Start date2021-02-15→2021-04-15
2021-01-27
Study Status, Study Description v2
Start date2020-12→2021-02-15
Study description+30 characters
[...] ition to what is seen with a usual APD (e.g., risperidone). WeThe investigators believe that the 30-35% of individuals who show a 'super-AP [...] be diluted by the other non-responders like B2s. Therefore, wethe investigators postulate that >50% of B1 will show a unique therapeutic ac [...]
2020-10-20
Study Identification, Study Status v1
Study title-16 characters
1/5 - Selective Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)
2020-10-01
Original filing
The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, \~50% each) in order to enroll n=320 (B1 and B2) into the RCT.
Trial Details
NCT Number NCT04580134
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: National Institute of Mental Health (NIMH), Beth Israel Deaconess Medical Center, Hartford Hospital, University of Georgia, University of Chicago
Conditions Schizophrenia, Schizoaffective Disorder, Bipolar 1 Disorder
Enrollment 524 participants
Start Date 2022-03-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-11