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New treatment option for Psychosis; Acute
Official title Cerebellum-based Imaging Neural Markers for Antipsychotic Response
ClinicalTrials.gov ID: NCT07483294
What this study is testing
What is risperidone?
risperidone is an investigational medicine, being studied as a potential treatment for psychosis; acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 40
You may be able to join if
- Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic...
- Current positive symptoms rated \> 3 (moderate) on one or more of the Brief Psychiatric Rating Scale (BPRS) psychosis items: conceptual...
- 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.
You likely can't join if
- 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 people providing informed consent;
- Contraindications to antipsychotic monotherapy;
- Contraindications to MR imaging (e.g. pacemaker);
See the full eligibility 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...
- 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.
- 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 people providing informed consent;
- Contraindications to antipsychotic monotherapy;
- Contraindications to MR imaging (e.g. pacemaker);
- Pregnancy by self report.
The study team makes the final eligibility decision.
Where it's taking place
- Glen Oaks, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glen Oaks, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.