Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT04580134 for Schizophrenia, Schizoaffective Disorder, Bipolar 1 Disorder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
University of Texas Southwestern Medical CenterCLOZAPINE Response in Biotype-1 Phase 4 524 Randomized Double-Blind
Clinical Trial NCT04580134 is designed to study Treatment for Schizophrenia, Schizoaffective Disorder, Bipolar 1 Disorder. It is a Phase 4 interventional study that is recruiting, having started on March 1, 2022, with plans to enroll 524 participants. Led by University of Texas Southwestern Medical Center, it is expected to complete by April 1, 2026. The latest data from ClinicalTrials.gov was last updated on February 6, 2026.
Brief Summary
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 p...Show More
Detailed Description
The clinical hypotheses underlying this experiment are that (i) B1 individuals are uniquely responsive to the pharmacological properties of clozapine because they have low Intrinsic EEG Activity (IEA), an index of compromised cortical neuronal responsiveness. This is plausibly associated with both (ii) reduced excitatory and (iii) reduced inhibitory stimulation in cortex and that IEA will track this altered excitator...Show More
Official Title
Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)
Conditions
SchizophreniaSchizoaffective DisorderBipolar 1 DisorderOther Study IDs
- ( STU-2020-0989 )
NCT ID Number
Start Date (Actual)
2022-03-01
Last Update Posted
2026-02-06
Completion Date (Estimated)
2026-04-01
Enrollment (Estimated)
524
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Schizophrenia, Bipolar, Psychosis, Biomarker, Biotype, BSNIP, B-SNIP, IEA
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBiotype 1 - Clozapine (B1C) Target doses will be up to clozapine 500mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at b...Show More | clozapine Biotype 1 and Biotype 2 |
Placebo ComparatorBiotype 1 - Risperidone (B1R) Target doses will be up to risperidone 6mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at b...Show More | risperidone Biotype 1 and Biotype 2 |
Active ComparatorBiotype 2 - Clozapine (B2C) Target doses will be up to clozapine 500mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at b...Show More | clozapine Biotype 1 and Biotype 2 |
Placebo ComparatorBiotype 2 - Risperidone (B2R) Target doses will be up to risperidone 6mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at b...Show More | risperidone Biotype 1 and Biotype 2 |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in the PANSS total score | The change in the PANSS total score from the clinical trial baseline (W4) to the end of treatment (W18) will be a primary outcome measure. We predict that B1/clozapine will show a significantly larger change in the PANSS score from W4 to W18, compared to B1/risperidone, B2/clozapine and B2/risperidone. We will also examine the patterns of change in the PANSS score during the 'stable treatment' phase (W10-W18), across the same study groups. A mixed-effect repeated-measures ANCOVA \[2(Biotypes) × 2(clozapine/risperidone) × 2(time points\] will be used. We also predict that the reduction in the PANSS scores will correlate with increased IEA in B1/clozapine but not in B1/risperidone, B2/clozapine or B2/risperidone. Multivariate prediction models will be used. | Week 4, Week 10 and Week 18 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- 18-60y/o; males and females; all races and ethnicities; able to provide written informed consent; able to read, speak, and understand English; medically stable; meeting DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features (we will use DSM-IV to be consistent with prior B-SNIP samples); PANSS total score of ≥70 and at least one item scored ≥5 or two items scored ≥4 on PANSS Positive Subscale; normal baseline values for absolute neutrophil count (ANC above 1500/mm3)
- premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest, age-corrected standardized score); comorbid DSM-IV diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months; neurological (e.g., seizure disorder, stroke, traumatic brain injury with a loss of consciousness ≥ 30min) or severe medical condition (e.g., decompensated cardiovascular disorder, AIDS) that may affect central nervous system function; concomitant medications known to affect EEG properties (i.e., lithium, anticonvulsants, benzodiazepines) or strong CYP 1A2 inhibitors (e.g., ciprofloxacin, enoxacin) or strong CYP 3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital, rifampin) which cannot be safely discontinued; vulnerable populations (e.g., pregnant, nursing, incarcerated); unwilling to use reliable means of contraception; history of neuroleptic malignant syndrome; prior treatment with clozapine, 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 either clozapine or risperidone in lifetime, or a previously failed trial of either clozapine or risperidone at adequate doses in lifetime; history of drug reaction with eosinophilia and systemic symptoms syndrome (DRESS), also known as drug-induced hypersensitivity syndrome (DIHS); high risk for suicide defined as more than 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded; current homicidal ideation with plan and intent such that outpatient care is precluded.
University of Texas Southwestern Medical Center284 active studies to exploreStudy Responsible Party
Carol A. Tamminga, Principal Investigator, Chair, Department of Psychiatry, University of Texas Southwestern Medical Center
Study Central Contact
Contact: Asha Philip, 214-648-5276, [email protected]
Contact: Emily McNeil, 214-648-1683, [email protected]
5 Study Locations in 1 Countries
Connecticut
Hartford Healthcare, Hartford, Connecticut, 06106, United States
Dr. Godfrey Pearlson, Contact, 860-545-7757, [email protected]
Aarti Kotecha, Contact, 860-545-7767, [email protected]
Recruiting
Georgia
University of Georgia, Athens, Georgia, 30602, United States
Isaac Doss, Contact, 706-255-7445, [email protected]
Recruiting
Illinois
University of Chicago, Chicago, Illinois, 60615, United States
Sanjana Venkat, Contact, 773-230-6624, [email protected]
Aashana Daru, Contact, 773-230-6624, [email protected]
Recruiting
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115, United States
Gautami Shashidhar, Contact, 617-754-1244, [email protected]
Diane Beckman, Contact, 339-364-8464, [email protected]
Recruiting
Texas
UT Southwestern Medical Center, Dallas, Texas, 75235, United States
Asha Philip, Contact, 214-648-5276, [email protected]
Yelonda Williams, B.A, Contact, 214/645-2784, [email protected]
Recruiting