Neural Biomarkers of Clozapine Response

NCT03076346 | Completed

• 1 other identifier: STUDY19060115
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Clozapine has consistently shown to be a superior drug for psychosis in patients who do not respond to other treatments, but its mechanism of action remains unknown. The overall goal of this study is to examine the functional neural circuitry that underlies successful treatment with clozapine, which may lead to the identification of biomarkers that will allow for more efficient use of clozapine, as well as additional treatment targets for patients with refractory illness.

Conditions

Schizophrenia; Treatment-resistant Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in resting state functional connectivity with efficacious clozapine treatment

  The investigators will examine the functional circuitry associated with a reduction of psychotic symptoms assessed with the Brief Psychiatric Rating Scale.

  12 weeks

Secondary Outcomes (1)

• Baseline prediction of clozapine response

  12 weeks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with schizophrenia or schizoaffective disorder who have failed treatment with two antipsychotic drugs and are beginning treatment with clozapine.

You may qualify if:

• Current positive symptoms rated ≥4 (moderate) on one or more of these Brief Psychiatric Rating Scale items: hallucinatory behavior, unusual thought content and conceptual disorganization.
• Patient has failed two trials of treatment with antipsychotic drugs and the patient's clinical team is initiating clozapine.
• Age of 18 to 50.
• Patient is competent and willing to sign informed consent.
• For female patients, negative pregnancy test and agreement to use a medically accepted birth control method.
• Diagnosis of schizophrenia or schizoaffective disorder

You may not qualify if:

• Serious neurological or endocrine disorder.
• Any medical condition which requires treatment with a medication with psychotropic effects
• Significant risk of suicidal or homicidal behavior
• Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
• Contraindications to treatment with clozapine (e.g. failed response in past, or history of adverse reactions to treatment).
• Contraindications to magnetic resonance imaging (e.g. pacemaker).
• Female patients who are pregnant or breast feeding.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Wpic/Upmc

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Schizophrenia; Schizophrenia, Treatment-Resistant; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 10, 2017
• Study Start: September 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)