Assessment of Schizophrenia Patients' Clinical Study Experiences

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05948111
Collaborator
(none)
500
1
24
20.8

Study Details

Study Description

Brief Summary

The study seeks to delve into the firsthand experiences of patients diagnosed with schizophrenia who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

The data collected from this study will help improve future outcomes for all schizophrenia patients as well as those in under-represented demographic groups.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Insights From Participants: Candid Accounts of Schizophrenia Clinical Trials Patients
    Anticipated Study Start Date :
    Aug 1, 2024
    Anticipated Primary Completion Date :
    Aug 1, 2025
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of schizophrenia patients who decide to enroll in a clinical trial [3 months]

    2. Rate of schizophrenia patients who remain in clinical trial to trial completion [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of schizophrenia

    • Considered reliable, able to understand, and willing to perform all study procedures

    • Signed Written Informed Consent

    Exclusion Criteria:
    • Currently enrolled in, have completed or have discontinued from a clinical trial involving an investigational drug

    • Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study

    • Any serious and/or unstable pre-existing medical disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Power Life Sciences San Francisco California United States 94107

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05948111
    Other Study ID Numbers:
    • 83338153
    First Posted:
    Jul 17, 2023
    Last Update Posted:
    Jul 17, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 17, 2023