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KAPPTIVATE1001NCT07615426

A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 8 sites
  2. Study completion pushed from Jul 5, 2027 to Dec 3, 2027
  3. Eligibility criteria expanded, about 10 words
  4. Study completion date: Jun 21, 2027 to Jul 5, 2027v3
  5. Study sites: 7 to 8v2
  6. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Screen Pass Rate
Timeframe: Up to 28 days
Exploratory Assessment-Specific Completion Rate
Timeframe: Up to 126 days
Total Assessment Completion Rate
Timeframe: Up to 126 days
Study Completion Rate
Timeframe: Up to 126 days
Adverse Events (AEs) Including AEs of Special Interest (AESI)
Timeframe: Up to 126 days
Number of Participants with Abnormalities in Vital Signs
Timeframe: Up to 126 days
Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Timeframe: Up to and including 85 days
Number of Participants with Abnormalities in Laboratory Parameters
Timeframe: Up to and including 85 days
Number of Participants Reporting Changes in Body Weight
Timeframe: Up to and including 85 days
Number of Participants Reporting Changes in Body Mass Index (BMI)
Timeframe: Up to and including 85 days
Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time
Timeframe: Up to 126 days
Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score
Timeframe: Up to and including 85 days

Arms and interventions

Arm A: AticaprantExperimental

Participants will receive aticaprant during the double blind (DB) treatment phase.

Arm B: PlaceboPlacebo comparator

Participants will receive placebo during the DB treatment phase.

Drugs: Aticaprant, Placebo

Sites

8 sites in 1 country