Evaluating clozapine's effectiveness in specific psychosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the response to clozapine in individuals with schizophrenia, schizoaffective disorder, and bipolar I disorder who are classified as Biotype-1. The study employs a randomized, double-blinded, parallel group design across five sites, comparing clozapine's effects against risperidone in a controlled setting. The researchers aim to determine if Biotype-1 patients, characterized by low Intrinsic EEG Activity, show a unique therapeutic response to clozapine, which may differ from the response of Biotype-2 patients. A total of 320 participants will be enrolled from an initial screening of 524 individuals with psychosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hartford Healthcare
  Hartford, Connecticut, United States Recruiting
• University of Georgia
  Athens, Georgia, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Carol Tamminga, M.D. — University of Texas Southwestern Medical Center
• Study coordinator: Asha Philip
• Email: asha.philip@utsouthwestern.edu
• Phone: 214-648-5276

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding early psychosis and its biological markers

  This study is trying to find out more about early signs of psychotic disorders like schizophrenia and bipolar disorder by looking at brain scans and other health data from around 320 participants over a year.

  Recruiting at 6 sites Beth Israel Deaconess Medical Center · Hartford, Connecticut and 5 other locations · NCT06740383

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• State Representation in Early Psychosis 2

  This observational study tests how people with early psychosis and healthy individuals use state information during tasks and how brain activity supports it.

  Recruiting at 2 sites University of Minnesota · Minneapolis, Minnesota and 1 other locations · NCT07834203

• Trying the Kiso Mind smartphone app for people with schizophrenia spectrum disorders

  This study tests whether the Kiso Mind smartphone app is acceptable, practical, and helpful for adults with schizophrenia or schizoaffective disorder alongside their usual care.

  Recruiting Charite University, Berlin, Germany · Berlin, State of Berlin · NCT07395206

• Valbenazine for adults with tardive dyskinesia who remain symptomatic on or after a VMAT2 inhibitor

  This trial will test whether valbenazine reduces involuntary movements in adults with tardive dyskinesia who still have symptoms while taking or after stopping a VMAT2 inhibitor.

  Recruiting at 19 sites Phase 4 Neurocrine Biosciences · Bryant, Arkansas and 18 other locations · NCT07105111

• Using AI to Improve Rehabilitation for Patients with Severe Mental Disorders

  This study is testing if using AI and fun games can help people with severe mental disorders improve their social skills and get back into the community.

  Recruiting Shanghai Mental Health Center · Shanghai · NCT06904079

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.