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RecruitingPhase 4

Cerebellum-based Imaging Neural Markers for Antipsychotic Response

Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis

Who can join

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

Age
15 Years to 40 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

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

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and subsequently be treated with either risperidone or aripiprazole for 12 weeks."
Compensation
Not stated
  • 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 uses MRI brain scans to look for signs linked to how people respond to medicines for psychosis, which can make it hard to tell what is real. It is for people ages 15 to 40 having their first episode of psychosis. Participants will take risperidone or aripiprazole for 12 weeks and have their symptoms checked several times.

This study plans to collect 120 patients with first-episode psychosis. Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and subsequently be treated with either risperidone or aripiprazole for 12 weeks. Clinical assessments for psychotic symptoms will be followed multiple times during the treatment until the 12th week. Data analysis will be conducted at the Psychiatric Research Unit of the Zucker Hillside Hospital.

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

Eligibility

Who can join

  • Are 15 to 40 years old.
  • Have a first episode of a psychotic disorder, including schizophrenia or related disorders, or bipolar disorder or major depression with psychosis.
  • Score above 3 (moderate) on at least one symptom rating for confused thinking, feeling unusually powerful or important, seeing or hearing things that are not there, or unusual thoughts.
  • Have taken medicines for psychosis for a total of 8 weeks or less in your lifetime.
  • Can understand the study and sign a form agreeing to join.

Who can't join

  • Have a serious brain, nerve, or hormone disorder, or a brain injury.
  • Have a medical condition that needs medicine affecting mood, thinking, or behavior.
  • Have a serious risk of harming yourself or killing someone else.
  • Have thinking, language, or other problems that prevent you from understanding and agreeing to join.
  • Have a medical reason you cannot safely be treated with just one medicine for psychosis.
  • Cannot safely have an MRI scan, for example because you have a pacemaker.
  • Report that you are pregnant.

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

Official eligibility criteria

Inclusion Criteria: * Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder Not Otherwise Specified (NOS), bipolar disorder with psychosis, and major depressive disorder with psychosis; * Current positive symptoms rated \> 3 (moderate) on one or more of the Brief Psychiatric Rating Scale (BPRS) psychosis items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content; * At early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 8 weeks or less; * Age 15 to 40; * Competent to sign informed consent. Exclusion Criteria: * Serious neurological or endocrine disorder or brain trauma; * 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 antipsychotic monotherapy; * Contraindications to MR imaging (e.g. pacemaker); * Pregnancy by self report.

Study sites (1)

NY