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Cerebellum-based Imaging Neural Markers for Antipsychotic Response

Study acronym: CINEMA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase changed: not specified → Phase 4 Trial arms changed: 0 → 1 · Interventions: Risperidone (Drug) to aripiprazole (Drug), risperidone (Drug) · Eligibility criteria revised · 1 morev3 Show 4 more changesShow less
    • Trial arms changed: 0 → 1
    • Interventions: Risperidone (Drug) to aripiprazole (Drug), risperidone (Drug)
    • Eligibility criteria revised
    • Study description expanded, about 70 words

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 7 words Secondary endpoints: details revised at 1 of 1 entryv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07483294
Lead Sponsor Northwell Health
Collaborators: National Institute of Mental Health (NIMH)
Conditions Psychosis; Acute
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov