Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bipolar 1 Disorder
- Schizoaffective Disorder
- Schizophrenia
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Individuals who previously participated in a B-SNIP trial who have already been biotyped will be grouped accordingly. New incoming individuals will have their Biotype completed. Those with Biotypes 1 and 2 will be recruited into this protocol. Anyone with Biotype 3 will be excluded from this protocol, but their information will be retained for use in a later study. Biotypes 1 and 2 will be separated into two groups. Each Biotype, B1 and B2, will be randomized between risperidone and clozapine to create parallel comparator groups.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: All participants and those who interact with them are blinded to study medication. The pharmacy dispensing team and the Safety Officer will remain unblinded for safety reasons.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
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 (...
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 excitatory/inhibitory balance and parallel clinical antipsychotic response. Furthermore, (iv) B2 probands (based on their high IEA) will not respond to clozapine. In this study clozapine response is measured by a 'super-APD' (AntiPsychotic Drug) drug response, a response in addition to what is seen with a usual APD (e.g., risperidone). The investigators believe that the 30-35% of individuals who show a 'super-APD' clozapine response in schizophrenia in the pivotal study will be predominantly in B1, because the B1 completers will no longer be diluted by the other non-responders like B2s. Therefore, the investigators postulate that >50% of B1 will show a unique therapeutic action of clozapine (beyond general APD action), contrasted with the usual predicted response of B1 to risperidone or of B2 to clozapine or risperidone.
Tracking Information
- NCT #
- NCT04580134
- Collaborators
- National Institute of Mental Health (NIMH)
- Beth Israel Deaconess Medical Center
- Hartford Hospital
- University of Georgia
- University of Chicago
- Investigators
- Not Provided
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