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RecruitingPhase 4

CLOZAPINE Response in Biotype-1

Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well clozapine works for people with psychosis in a group called Biotype-1 (B1), using risperidone as a comparison drug. It is for adults ages 18–60 with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychosis, which can make it hard to tell what is real.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18–60 years old. People of any sex, race, or ethnic background may join.
  • Can give written consent to join the study.
  • Can read, speak, and understand English.
  • Have stable physical health.
  • Have schizophrenia, schizoaffective disorder, or bipolar I disorder with psychosis, confirmed by a study interview.
  • Meet symptom score rules: a total PANSS score of at least 70, plus one positive-symptom score of at least 5 or two of at least 4. PANSS measures psychosis symptoms.
  • Have a normal starting count of neutrophils, white blood cells that fight infection, above 1,500/mm³.

Who can't join

  • Have an estimated past learning and thinking ability score below 70 on a word-reading test.
  • Had alcohol or drug abuse in the past month, or alcohol or drug dependence in the past 3 months.
  • Have a brain or nerve disorder, or a serious medical illness, that may affect brain function. Examples include seizures, stroke, or a head injury causing loss of consciousness for at least 30 minutes.
  • Take medicines that affect brain-wave tests or how the body processes study drugs and cannot safely stop them. Examples include lithium, some seizure medicines, benzodiazepines, and certain antibiotics.
  • Are pregnant, breastfeeding, in prison, or in another vulnerable group; or are unwilling to use reliable birth control.
  • Have ever taken clozapine; had unbearable side effects or an adequate-dose treatment that did not work with clozapine or risperidone; or recently received long-acting antipsychotic shots. This means a monthly shot within 3 months or a 3-month shot within 6 months.
  • Have had neuroleptic malignant syndrome, a serious reaction to antipsychotic drugs, or DRESS/DIHS, a serious drug reaction that can affect several organs.
  • Had more than one suicide attempt needing medical care in the past year, or any attempt in the past 3 months. Also excluded are people with current plans and intent to kill themselves or someone else that make outpatient care unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

Study sites (5)

CT

GA

IL

MA

TX